fylnetra

Generic: pegfilgrastim

Labeler: amneal pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name fylnetra
Generic Name pegfilgrastim
Labeler amneal pharmaceuticals llc
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

pegfilgrastim 6 mg/.6mL

Manufacturer
Amneal Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 70121-1627
Product ID 70121-1627_8cb6cfed-487e-4351-8f48-0be3cc5c2d6d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761084
Listing Expiration 2026-12-31
Marketing Start 2022-05-31

Pharmacologic Class

Established (EPC)
leukocyte growth factor [epc]
Chemical Structure
granulocyte colony-stimulating factor [cs]
Physiologic Effect
increased myeloid cell production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 701211627
Hyphenated Format 70121-1627

Supplemental Identifiers

RxCUI
2602781 2602787
UPC
0370121162711 0470121162718
UNII
3A58010674
NUI
M0024696 N0000009451 N0000175666

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name fylnetra (source: ndc)
Generic Name pegfilgrastim (source: ndc)
Application Number BLA761084 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/.6mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (70121-1627-1) / .6 mL in 1 SYRINGE
source: ndc

Packages (1)

70121-1627-1 1 SYRINGE in 1 CARTON (70121-1627-1) / .6 mL in 1 SYRINGE

Ingredients (1)

pegfilgrastim (6 mg/.6mL)

Linked Drug Pages (1)

FYLNETRA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "8cb6cfed-487e-4351-8f48-0be3cc5c2d6d", "openfda": {"nui": ["M0024696", "N0000009451", "N0000175666"], "upc": ["0370121162711", "0470121162718"], "unii": ["3A58010674"], "rxcui": ["2602781", "2602787"], "spl_set_id": ["eeadd641-573d-47fe-897a-61006e5f9e03"], "pharm_class_cs": ["Granulocyte Colony-Stimulating Factor [CS]"], "pharm_class_pe": ["Increased Myeloid Cell Production [PE]"], "pharm_class_epc": ["Leukocyte Growth Factor [EPC]"], "manufacturer_name": ["Amneal Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (70121-1627-1)  / .6 mL in 1 SYRINGE", "package_ndc": "70121-1627-1", "marketing_start_date": "20220531"}], "brand_name": "FYLNETRA", "product_id": "70121-1627_8cb6cfed-487e-4351-8f48-0be3cc5c2d6d", "dosage_form": "INJECTION", "pharm_class": ["Granulocyte Colony-Stimulating Factor [CS]", "Increased Myeloid Cell Production [PE]", "Leukocyte Growth Factor [EPC]"], "product_ndc": "70121-1627", "generic_name": "pegfilgrastim", "labeler_name": "Amneal Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "FYLNETRA", "active_ingredients": [{"name": "PEGFILGRASTIM", "strength": "6 mg/.6mL"}], "application_number": "BLA761084", "marketing_category": "BLA", "marketing_start_date": "20220531", "listing_expiration_date": "20261231"}