Prescription drug · BLA
Zymfentra (Infliximab-dyyb) NDC 72606-025
Kit · CELLTRION USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72606-025-01 | 7260600250172606002501 | 1 KIT in 1 CARTON (72606-025-01) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Mar 1, 2024 | |
| 72606-025-02 | 7260600250272606002502 | 2 KIT in 1 CARTON (72606-025-02) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Mar 1, 2024 | |
| 72606-025-03 | 7260600250372606002503 | 4 KIT in 1 CARTON (72606-025-03) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Mar 1, 2024 | |
| 72606-025-04 | 7260600250472606002504 | 6 KIT in 1 CARTON (72606-025-04) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Mar 1, 2024 | |
| 72606-025-05 | 7260600250572606002505 | 1 KIT in 1 CARTON (72606-025-05) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Mar 1, 2024 | |
| 72606-025-06 | 7260600250672606002506 | 2 KIT in 1 CARTON (72606-025-06) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Mar 1, 2024 | |
| 72606-025-07 | 7260600250772606002507 | 4 KIT in 1 CARTON (72606-025-07) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Mar 1, 2024 | |
| 72606-025-08 | 7260600250872606002508 | 6 KIT in 1 CARTON (72606-025-08) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Mar 1, 2024 | |
| 72606-025-09 | 7260600250972606002509 | 1 KIT in 1 CARTON (72606-025-09) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Mar 1, 2024 | |
| 72606-025-10 | 7260600251072606002510 | 2 KIT in 1 CARTON (72606-025-10) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Mar 1, 2024 | |
| 72606-025-11 | 7260600251172606002511 | 4 KIT in 1 CARTON (72606-025-11) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Mar 1, 2024 | |
| 72606-025-12 | 7260600251272606002512 | 6 KIT in 1 CARTON (72606-025-12) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY / 1 mL in 1 SYRINGE * 1 mL in 1 PACKETMarketed from Mar 1, 2024 |
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
- Dosage form
- Kit
- Labeler
- CELLTRION USA Inc.NDC labeler code 72606
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761358
- Marketing start
- Listing expires
- Identifiers
- Product ID 72606-025_e81d34f1-0902-43ef-ab88-470bcc6c0544SPL ID e81d34f1-0902-43ef-ab88-470bcc6c0544SPL set ID 93a193ab-9f96-4da6-aa7c-31212e81879aRxCUI 797544, 2675742, 2675749, 2675753, 2675757UNII B72HH48FLU
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.
- NDC on a medical claim
N472606002501followed by a unit qualifier and the quantityPackage 72606-0025-01. 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.
About NDC 72606-025
- What is NDC 72606-025?
- 72606-025 is the product NDC for Zymfentra (infliximab-dyyb) kit, listed with the FDA by CELLTRION USA Inc.. It has 12 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Zymfentra (Infliximab-dyyb).
- Who is the labeler?
- CELLTRION USA Inc., NDC labeler code 72606. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Zymfentra?
- 1 other product NDC are listed under this name. See all Zymfentra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Zymfentra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Zymfentrainfliximab-dyyb | Infliximab-dyyb 120 mg/mL | InjectionSubcutaneous | CELLTRION USA Inc. | 72606-047 | 72606-0047-01 |
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 | Infliximab-dyyb 120 mg/mL | InjectionSubcutaneous | CELLTRION USA Inc. | 72606-047 |