Prescription drug · BLA
Zymfentra (infliximab-dyyb) NDC 72606-047
Infliximab-dyyb 120 mg/mL · Injection · Subcutaneous · CELLTRION USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72606-047-01 | 72606004701 | 1 SYRINGE in 1 CARTON (72606-047-01) / 1 mL in 1 SYRINGEMarketed from Mar 1, 2024 · Sample package |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Zymfentra
- Generic name (nonproprietary)
- infliximab-dyyb
- Active ingredients
- Infliximab-dyyb — 120 mg/mL
- Dosage form
- Injection
- Route
- Subcutaneous
- Labeler
- CELLTRION USA Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761358
- Marketing start
- Listing expires
- Other FDA classes
- Tumor Necrosis Factor Receptor Blocking Activity (Mechanism)
- Identifiers
- Product ID 72606-047_e81d34f1-0902-43ef-ab88-470bcc6c0544SPL ID e81d34f1-0902-43ef-ab88-470bcc6c0544SPL set ID 93a193ab-9f96-4da6-aa7c-31212e81879aRxCUI 797544, 2675742, 2675749, 2675753, 2675757UNII B72HH48FLU
- Pharmacologic class
- Tumor Necrosis Factor Blocker
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N472606004701followed by a unit qualifier and the quantityPackage 72606-0047-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
ZYMFENTRA is a tumor necrosis factor (TNF) blocker indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. ( 1 ) moderately to severely active Crohn’s disease following with an infliximab products administered intraneously. ( 1 ) ZYMFENTRA is indicated in adults for maintenance treatment of: moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously. moderately to severely active Crohn's disease following treatment with an infliximab product administered intravetnously.
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761358
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Zymfentrainfliximab-dyyb | — | Kit | CELLTRION USA Inc. | 72606-025 |