Prescription drug · BLA
Nypozi (Filgrastim-txid) NDC 69097-430
Filgrastim 300 ug/300ug · Injection · Intravenous, Subcutaneous · Cipla USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-430-67 | 6909704306769097043067 | 1 SYRINGE, GLASS in 1 CARTON (69097-430-67) / 300 ug in 1 SYRINGE, GLASSMarketed from Feb 11, 2026 | |
| 69097-430-96 | 6909704309669097043096 | 10 SYRINGE, GLASS in 1 CARTON (69097-430-96) / 300 ug in 1 SYRINGE, GLASSMarketed from Feb 11, 2026 |
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)
- Nypozi
- Generic name (nonproprietary)
- filgrastim-txid
- Active ingredients
- Filgrastim — 300 ug/300ug
- Dosage form
- Injection
- Route
- Intravenous, Subcutaneous
- Labeler
- Cipla USA Inc.NDC labeler code 69097
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761126
- Marketing start
- Listing expires
- Other FDA classes
- Granulocyte Colony-Stimulating Factor (Chemical structure)Increased Myeloid Cell Production (Physiologic effect)
- Identifiers
- Product ID 69097-430_6951a2d4-8d07-4197-a02c-2e5aed420f33SPL ID 6951a2d4-8d07-4197-a02c-2e5aed420f33SPL set ID 575d164d-45fa-4e3e-81e4-2652d96673d1RxCUI 2700369, 2700376, 2700378, 2700379UNII PVI5M0M1GW
- Pharmacologic class
- Leukocyte Growth Factor
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
N469097043067followed by a unit qualifier and the quantityPackage 69097-0430-67. 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 .
Indications (excerpt from the label)
NYPOZI is a leukocyte growth factor indicated to: Decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever ( 1.1 ) Reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML) ( 1.2 ) Reduce the duration of neutropenia and neutropenia-related clinical sequelae, e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT…
Excerpt only. Read the full label for complete information.
About NDC 69097-430
- What is NDC 69097-430?
- 69097-430 is the product NDC for Nypozi (filgrastim-txid), Filgrastim 300 ug/300ug injection, listed with the FDA by Cipla USA Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Nypozi (Filgrastim-txid).
- What is the active ingredient?
- Filgrastim.
- Who is the labeler?
- Cipla USA Inc., NDC labeler code 69097. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Nypozi?
- 1 other product NDC are listed under this name. See all Nypozi NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Nypozi products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Nypozifilgrastim-txid | Filgrastim 480 ug/480ug | InjectionIntravenous, Subcutaneous | Cipla USA Inc. | 69097-429 | 69097-0429-6769097-0429-96 |
Other NDCs under BLA 761126
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 |
|---|---|---|---|---|
| Nypozifilgrastim-txid | Filgrastim 480 ug/480ug | InjectionIntravenous, Subcutaneous | Cipla USA Inc. | 69097-429 |
| NYPOZI txidfilgrastim-txid | Filgrastim 300 ug/300ug | InjectionIntravenous, Subcutaneous | Tanvex BioPharma USA, Inc. | 72374-101 |
| NYPOZI txidfilgrastim-txid | Filgrastim 480 ug/480ug | InjectionIntravenous, Subcutaneous | Tanvex BioPharma USA, Inc. | 72374-102 |