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NDC 70121-1627-01 FYLNETRA 6 mg/.6mL Details
FYLNETRA 6 mg/.6mL
FYLNETRA is a SUBCUTANEOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amneal Pharmaceuticals LLC. The primary component is PEGFILGRASTIM.
MedlinePlus Drug Summary
Pegfilgrastim injection products are used to reduce the chance of infection in people who have certain types of cancer and are receiving chemotherapy medications that may decrease the number of neutrophils (a type of blood cell needed to fight infection). Pegfilgrastim injection (Neulasta) is also used to increase the chance of survival in people who have been exposed to harmful amounts of radiation, which can cause severe and life-threatening damage to bone marrow. Pegfilgrastim is in a class of medications called colony stimulating factors. It works by helping the body make more neutrophils.
Related Packages: 70121-1627-01Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Pegfilgrastim Injection
Product Information
| NDC | 70121-1627 |
|---|---|
| Product ID | 70121-1627_b512ecac-1a1c-41ad-bbeb-f46cc90c1333 |
| Associated GPIs | |
| GCN Sequence Number | 083437 |
| GCN Sequence Number Description | pegfilgrastim-pbbk SYRINGE 6 MG/0.6ML SUBCUT |
| HIC3 | N1C |
| HIC3 Description | LEUKOCYTE (WBC) STIMULANTS |
| GCN | 52395 |
| HICL Sequence Number | 048035 |
| HICL Sequence Number Description | PEGFILGRASTIM-PBBK |
| Brand/Generic | Brand |
| Proprietary Name | FYLNETRA |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | pegfilgrastim |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 6 |
| Active Ingredient Units | mg/.6mL |
| Substance Name | PEGFILGRASTIM |
| Labeler Name | Amneal Pharmaceuticals LLC |
| Pharmaceutical Class | Granulocyte Colony-Stimulating Factor [CS], Granulocyte-Macrophage Colony-Stimulating Factor [CS], Increased Myeloid Cell Production [PE], Leukocyte Growth Factor [EPC] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA761084 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 70121-1627-01 (70121162701)
| NDC Package Code | 70121-1627-1 |
|---|---|
| Billing NDC | 70121162701 |
| Package | 1 SYRINGE in 1 CARTON (70121-1627-1) / .6 mL in 1 SYRINGE |
| Marketing Start Date | 2022-05-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |