Infliximab products
Reference originator and four biosimilars, plus the subcutaneous maintenance product. All IV products share one unit basis (10 mg), the same FDA boxed warnings, and the same indication panel, but each has its own HCPCS code, NDC, and manufacturer. ASP comparison lives in Current Remicade pricing.
| Brand | J-code | Manufacturer | Generic | Vial |
|---|---|---|---|---|
| Remicade (originator) | J1745 | Janssen Biotech | infliximab | 100 mg single-dose vial |
| Inflectra | Q5103 | Pfizer / Celltrion | infliximab-dyyb | 100 mg single-dose vial |
| Renflexis | Q5104 | Samsung Bioepis / Organon | infliximab-abda | 100 mg single-dose vial |
| Avsola | Q5121 | Amgen | infliximab-axxq | 100 mg single-dose vial |
| Ixifi | Q5109 | Pfizer | infliximab-qbtx | 100 mg single-dose vial — discontinued / limited supply |
| Zymfentra (SC maintenance) | J1748 | Celltrion | infliximab-dyyb | Prefilled syringe/pen (SC) — pharmacy benefit |
Zymfentra (infliximab-dyyb SC, J1748) is the subcutaneous maintenance product for Crohn's disease and ulcerative colitis after IV induction, and is billed under its own permanent J-code — it is not interchangeable with any of the five IV codes above.
Inflectra (Q5103)
Pfizer / Celltrion · lead NDC 0069-0809-01 (11-digit claim form: 00069-0809-01) · 100 mg single-dose vial, same 1 unit = 10 mg basis as Remicade.
Renflexis (Q5104)
Organon / Samsung Bioepis · lead NDC 78206-162-01 (11-digit claim form: 78206-0162-01) · 100 mg single-dose vial.
Avsola (Q5121)
Amgen · lead NDC 55513-203-01 (11-digit claim form: 55513-0203-01) · 100 mg single-dose vial.
Ixifi (Q5109)
Pfizer · lead NDC 0069-0331-01 (11-digit claim form: 00069-0331-01) · discontinued / limited supply — verify availability before billing.
Remicade dosing by indication
Induction runs at weeks 0, 2, and 6 for every indication, dosed by weight (mg/kg); maintenance then varies by indication.
| Indication | Induction | Maintenance | Notes |
|---|---|---|---|
| Rheumatoid arthritis (RA) | 3 mg/kg IV at weeks 0, 2, 6 | 3 mg/kg q8wk thereafter | Required combination with methotrexate. For incomplete response, the dose may be adjusted up to 10 mg/kg, or dosing as often as every 4 weeks may be considered. |
| Ankylosing spondylitis (AS) | 5 mg/kg IV at weeks 0, 2, 6 | 5 mg/kg q6wk thereafter | Per FDA label. |
| Psoriatic arthritis (PsA) | 5 mg/kg IV at weeks 0, 2, 6 | 5 mg/kg q8wk thereafter | With or without methotrexate. |
| Plaque psoriasis | 5 mg/kg IV at weeks 0, 2, 6 | 5 mg/kg q8wk thereafter | Adult patients with chronic severe plaque psoriasis. |
| Crohn's disease (adult) | 5 mg/kg IV at weeks 0, 2, 6 | 5 mg/kg q8wk thereafter | Moderate-to-severe and fistulizing CD. May escalate to 10 mg/kg for loss of response. |
| Pediatric Crohn's disease | 5 mg/kg IV at weeks 0, 2, 6 (ages 6+) | 5 mg/kg q8wk thereafter | Same dosing schedule as adults; weight calculated by kg. |
| Ulcerative colitis (adult) | 5 mg/kg IV at weeks 0, 2, 6 | 5 mg/kg q8wk thereafter | Moderate-to-severe UC. |
| Pediatric ulcerative colitis | 5 mg/kg IV at weeks 0, 2, 6 (ages 6+) | 5 mg/kg q8wk thereafter | Same dosing schedule as adults. |
Premedications
Common premedication regimens include diphenhydramine, acetaminophen, and hydrocortisone, with hydrocortisone reserved for patients with prior infusion reactions or a higher-risk profile. Each agent bills its own admin code and J-code, separate from the infliximab administration. The prescribing clinician sets the protocol.
First-dose administration setting
Because of the FDA-flagged risk of acute infusion reactions and the ~2-hour minimum infusion time, first doses are typically administered in a setting with immediate access to resuscitation (hospital outpatient, AIC, or office equipped with emergency medications). Subsequent doses can move to lower-cost sites of care per payer site-of-care UM rules.
Need the billing units for a patient? Convert dose to J1745 billing units →
Remicade billing reference
HCPCS
J1745 — 10 mg per billing unit. The same 10 mg unit basis applies to all five infliximab HCPCS codes (originator and biosimilars).
NDCs
Lead NDC 57894-030-01 (Remicade, Janssen Biotech labeler 57894). Pad to 11 digits with a leading zero in the appropriate segment for CMS-1500 Box 24A.
| NDC (10-digit) | NDC (11-digit, claim form) | Package |
|---|---|---|
57894-030-01 | 57894-0030-01 | 100 mg single-dose lyophilized vial |
Inflectra (Q5103) — Pfizer labeler 0069
| NDC (10-digit) | NDC (11-digit, claim form) | Package |
|---|---|---|
0069-0809-01 | 00069-0809-01 | 100 mg single-dose lyophilized vial |
Renflexis (Q5104) — Organon / Samsung Bioepis labeler 78206
| NDC (10-digit) | NDC (11-digit, claim form) | Package |
|---|---|---|
78206-162-01 | 78206-0162-01 | 100 mg single-dose lyophilized vial |
Avsola (Q5121) — Amgen labeler 55513
| NDC (10-digit) | NDC (11-digit, claim form) | Package |
|---|---|---|
55513-203-01 | 55513-0203-01 | 100 mg single-dose lyophilized vial |
Ixifi (Q5109) — Pfizer labeler 0069 — discontinued / limited supply
| NDC (10-digit) | NDC (11-digit, claim form) | Package |
|---|---|---|
0069-0331-01 | 00069-0331-01 | 100 mg single-dose lyophilized vial — verify availability before billing |
N4 qualifier in CMS-1500 Box 24A shaded area with unit of measure and quantity actually drawn from the vial.
Administration
Common Remicade administration coding uses 96413 (initial hour) and 96415 (each additional hour) — CPT's chemotherapy/complex-biologic infusion administration codes. Some payers require the non-chemotherapy pair (96365/96366) instead; follow the payer's policy.
| CPT | Description | Use for |
|---|---|---|
96413 | Chemotherapy administration, IV infusion technique; up to 1 hour, single or initial substance | First hour of infliximab infusion ($133.27, Medicare PFS national non-facility, 2026) |
96415 | Chemotherapy administration, IV infusion technique; each additional hour | Hours 2+ of infliximab infusion ($28.39, Medicare PFS national non-facility, 2026) |
96367 | IV infusion, additional sequential infusion of new substance | Concurrent premed infusions (separate substance) per AMA hierarchy rules |
96374 | Therapeutic IV push, single drug | IV-push premedications |
96372 | Therapeutic SC/IM injection | SC/IM premedications |
Premedication billing
| Agent | Route / CPT | Use |
|---|---|---|
| Diphenhydramine | Oral, or IV push (96374) | Antihistamine premedication |
| Acetaminophen | Oral | Antipyretic premedication |
| Hydrocortisone | IV push (96374) | Selected patients with prior infusion reactions |
Modifiers
JZ — required when no drug discarded. JW — required for documented waste of unused single-dose-vial drug. JW applies to most infliximab infusions because dosing is weight-based and 100 mg vials rarely match the calculated dose exactly.
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. For infliximab, JZ applies when the calculated mg dose is an exact multiple of 100 mg (the vial size) — no waste. Append JZ to the J1745 / Q5103 / Q5104 / Q5121 / Q5109 line.
For most weight-and-dose combinations, the calculated mg dose is not an exact multiple of 100 mg, so partial-vial waste is the rule. CMS requires the JW modifier on a separate claim line for the discarded units (rounded per CMS rules), with the wastage documented in the medical record. Bill administered units (no wastage modifier) and discarded units (with JW) on two separate lines, same date of service, same HCPCS code.
TB — 340B drug pricing. Hospitals that purchase infliximab through 340B and bill Medicare report the TB modifier — the sole 340B identifier since CMS discontinued JG on January 1, 2025. Most infusion suites do not use 340B pricing; only the hospital-outpatient setting does.
Modifier 25 — same-day E/M. Append modifier 25 to the same-day E/M code if a significant, separately identifiable evaluation occurred. Routine pre-infusion check-in is bundled.
Claim form
CMS-1500 / 837P (physician office, AIC; POS 11/49) field map for a J1745 claim.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | Format: N4 qualifier + 11-digit NDC + UN + quantity drawn |
| HCPCS J1745 (administered; JZ only if no waste) | 24D (drug line) | Administered units, per MAC rounding |
| HCPCS J1745 + JW (when waste) | 24D (separate line) | Discarded units, per MAC rounding |
| Drug units | 24G | Administered + waste split across two lines, same DOS |
| CPT 96413 + 96415 | 24D (admin lines) | 1 unit 96413 (initial hour) + 1 unit 96415 (each additional hour) |
| ICD-10 | 21 | Indication-specific |
| NPI | 17b / 24J / 33a | Rendering and billing provider NPI |
| PA number (when required) | 23 | Required by most payers for non-preferred Remicade in 2026 |
| TB modifier (340B sites only) | 24D | Hospital outpatient 340B claims only |
Remicade coverage
- 25 of 30 commercial payer policy sets require prior authorization
- 20 name a preferred infliximab product
- Requirements vary by diagnosis, payer and site of care
- As of 2026, UnitedHealthcare requires biosimilar use unless documented medical necessity for Remicade; Aetna and Cigna prefer the lowest-cost biosimilar option
- UnitedHealthcare, Aetna, Cigna, and most BCBS plans apply site-of-care utilization management to specialty infusion drugs
- After tolerated infusions, payers typically require subsequent doses to move out of hospital outpatient into office or an in-network ambulatory infusion center
ICD-10 codes by indication
Use the most specific code supported by chart documentation. Each indication has a distinct code family.
| Indication | ICD-10 family | Examples |
|---|---|---|
| Rheumatoid arthritis (RA) | M05.x / M06.x | M05.79; M06.09; M05.9 |
| Ankylosing spondylitis (AS) | M45.x | M45.0; M45.9 |
| Psoriatic arthritis (PsA) | L40.5x / M07.x | L40.50; L40.51; L40.52; L40.59 |
| Plaque psoriasis | L40.x | L40.0; L40.9 |
| Crohn's disease (adult + pediatric) | K50.x | K50.00/K50.01x; K50.10/K50.11x; K50.90/K50.91x |
| Ulcerative colitis (adult + pediatric) | K51.x | K51.00/K51.01x; K51.90/K51.91x |
See Medicare covered diagnoses for infliximab for the MAC-level ICD-10 ranges.
Site of care / POS
Payer site-of-care UM and the patient's reaction-risk profile decide the first-dose setting: office (POS 11), AIC (POS 49), or hospital outpatient (POS 22 on-campus, 19 off-campus). Subsequent doses move to the lowest-cost site the plan allows.
| Setting | POS | Claim form | Electronic | Typical use |
|---|---|---|---|---|
| Physician office / infusion suite | 11 | CMS-1500 | 837P | Most maintenance doses |
| Ambulatory infusion center (AIC) | 49 | CMS-1500 | 837P | Maintenance post site-of-care steering |
| On-campus hospital outpatient | 22 | UB-04 / CMS-1450 | 837I | First dose, reaction history |
| Off-campus hospital outpatient | 19 | UB-04 / CMS-1450 | 837I | First dose at off-campus HOPD |
| Patient home | 12 | CMS-1500 | 837P | Home infusion permitted by some payers (verify) |
Check the patient's actual policy: See Remicade coverage by payer →
Current Remicade pricing
Medicare ASP+6%: $31.479 / 10 mg · $1,259.16 / 400 mg. Sequestration reduces Medicare's 80% share by 2% (effective ASP+4.3% overall). Commercial plans pay a contracted rate that differs by payer and state.
| Product | HCPCS | Rate / 10 mg | Rate / 400 mg |
|---|---|---|---|
| Remicade | J1745 | $31.479 | $1,259.16 |
| Inflectra | Q5103 | $27.710 | $1,108.40 |
| Renflexis | Q5104 | $26.615 | $1,064.60 |
| Avsola | Q5121 | $30.830 | $1,233.20 |
Look up commercial reimbursement →
Patient cost
The patient's actual responsibility depends on: payer allowed rate · benefits · − assistance · = patient responsibility.
Calculate a Remicade patient estimate →
Copay & financial assistance
Commercial: J&J withMe savings available for eligible patients. Medicare: diagnosis-specific charitable funds may be available.
Common Remicade denials & fixes
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong admin-code family for this payer | Biller used one admin-code family without checking this payer's policy | Most payers accept 96413 + 96415; if this payer requires the non-chemotherapy pair (96365 + 96366) instead, resubmit with that. |
| Wrong unit count (10× over- or under-bill) | Biller defaulted to 1 mg/unit instead of 10 mg/unit | Recalculate: mg ÷ 10 = units. |
| Wrong J-code (J1745 instead of biosimilar) | Reference Remicade billed when patient received a biosimilar | Match HCPCS to NDC drawn: Q5103/Q5104/Q5121/Q5109 each have distinct labelers. |
| Biosimilar mandate not met (UHC) | New start on J1745 without documented biosimilar trial or contraindication | Submit biosimilar trial documentation OR clinical justification for a Remicade override. |
| JZ missing | Single-dose-vial claim without JZ when no drug was discarded | Resubmit with JZ on the drug line. |
| JW missing on weight-based claim | mg/kg dose with vial waste not reported | Add a separate line with JW for discarded units; document waste in chart. |
| TB screening not documented | Payer requests pre-treatment latent TB testing | Confirm pre-treatment PPD or IGRA result in chart; supply on appeal. |
| Combination-with-MTX requirement (RA only) | RA dose billed without methotrexate documentation | Document MTX use in chart and supply on appeal. |
| Site-of-care denial post first dose | Subsequent infusion at HOPD when payer requires office/AIC | Move infusion to office or AIC, or submit medical-necessity justification. |
| Looking for Zymfentra under J1745 | Zymfentra (SC infliximab-dyyb) does not appear on medical-benefit claim feed | Zymfentra has its own permanent code J1748; look there, not J1745 or any IV Q-code. |
Frequently asked questions
What are the HCPCS codes for infliximab?
There are five infliximab HCPCS codes: J1745 (Remicade — originator), Q5103 (Inflectra), Q5104 (Renflexis), Q5121 (Avsola), and Q5109 (Ixifi, discontinued / limited supply). All five share the same billing unit basis: 1 unit = 10 mg. Zymfentra (subcutaneous infliximab-dyyb) is billed separately under its own permanent J-code J1748.
Why does the biller need to distinguish Remicade from biosimilars?
Each infliximab product has its own HCPCS code, NDC, and ASP. Billing Remicade (J1745) when the patient received Inflectra (Q5103) triggers a denial. As of 2026, UnitedHealthcare requires documented medical necessity to bill Remicade over a biosimilar; Aetna and Cigna prefer the lowest-cost biosimilar.
What is the dosing for infliximab by indication?
Standard regimens (all IV induction at 0, 2, 6 weeks, then maintenance):
- RA = 3 mg/kg every 8 weeks in combination with methotrexate (for incomplete response, the dose may be adjusted up to 10 mg/kg, or dosing as often as every 4 weeks may be considered)
- Ankylosing spondylitis = 5 mg/kg every 6 weeks
- Psoriatic arthritis = 5 mg/kg every 8 weeks
- Plaque psoriasis = 5 mg/kg every 8 weeks
- Crohn's disease (adult and pediatric) = 5 mg/kg every 8 weeks (may escalate to 10 mg/kg for loss of response)
- Ulcerative colitis (adult and pediatric) = 5 mg/kg every 8 weeks
What FDA boxed warnings apply to all infliximab products?
All five infliximab products carry the same FDA boxed warnings: (1) serious infections — TB reactivation (latent TB screening required pre-therapy), invasive fungal infections, bacterial sepsis, opportunistic pathogens; (2) malignancies — lymphoma and other malignancies, including hepatosplenic T-cell lymphoma (HSTCL) in adolescent and young adult patients receiving infliximab plus thiopurines for IBD. Before the first infusion the chart should carry latent TB screening (PPD or IGRA), hepatitis B serology and a chest radiograph — payers request that documentation on appeal, and a missing result is a denial reason in its own right.
Is Remsima SC / Zymfentra the same as Remicade?
No — Zymfentra (infliximab-dyyb subcutaneous, Celltrion), FDA-approved October 2023 as the first subcutaneous infliximab for maintenance after IV induction, doesn't bill under any of the five IV infliximab codes. CMS assigned it the permanent J-code J1748 in 2025.
Sources
- AAPC — HCPCS J1745 (Remicade / infliximab)
- AAPC — HCPCS Q5103 (Inflectra)
- AAPC — HCPCS Q5104 (Renflexis)
- AAPC — HCPCS Q5121 (Avsola)
- AAPC — HCPCS Q5109 (Ixifi)
- FDA Remicade label (BLA 103772)
- J&J withMe — Remicade HCP resources
- UnitedHealthcare — Commercial Medical Drug policy database
- CMS — Medicare Part B Drug ASP Pricing File
- CMS — HCPCS quarterly update file
- CMS — JW / JZ modifier guidance
Dataset dates: pricing Q3 2026 · payer policies Aug 2026 · assistance Sep 2026.