nivestym

Generic: filgrastim-aafi

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name nivestym
Generic Name filgrastim-aafi
Labeler pfizer laboratories div pfizer inc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS SUBCUTANEOUS
Active Ingredients

filgrastim 480 ug/1.6mL

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-0294
Product ID 0069-0294_e73179c2-1306-443c-a5ed-d2748e96147c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761080
Listing Expiration 2026-12-31
Marketing Start 2019-03-11

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 00690294
Hyphenated Format 0069-0294

Supplemental Identifiers

RxCUI
2057200 2057205 2057209 2057212 2057215 2057216 2057218 2057219
UNII
PVI5M0M1GW
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 nivestym (source: ndc)
Generic Name filgrastim-aafi (source: ndc)
Application Number BLA761080 (source: ndc)
Routes
INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 480 ug/1.6mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (0069-0294-10) / 1.6 mL in 1 VIAL, SINGLE-DOSE (0069-0294-01)
source: ndc

Packages (1)

0069-0294-10 10 VIAL, SINGLE-DOSE in 1 CARTON (0069-0294-10) / 1.6 mL in 1 VIAL, SINGLE-DOSE (0069-0294-01)

Ingredients (1)

filgrastim (480 ug/1.6mL)

Linked Drug Pages (1)

Nivestym ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "e73179c2-1306-443c-a5ed-d2748e96147c", "openfda": {"nui": ["M0024696", "N0000009451", "N0000175666"], "unii": ["PVI5M0M1GW"], "rxcui": ["2057200", "2057205", "2057209", "2057212", "2057215", "2057216", "2057218", "2057219"], "spl_set_id": ["d23ab39c-b6ec-41cf-a529-9dd2852c9d9a"], "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": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (0069-0294-10)  / 1.6 mL in 1 VIAL, SINGLE-DOSE (0069-0294-01)", "package_ndc": "0069-0294-10", "marketing_start_date": "20190311"}], "brand_name": "Nivestym", "product_id": "0069-0294_e73179c2-1306-443c-a5ed-d2748e96147c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Granulocyte Colony-Stimulating Factor [CS]", "Increased Myeloid Cell Production [PE]", "Leukocyte Growth Factor [EPC]"], "product_ndc": "0069-0294", "generic_name": "filgrastim-aafi", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Nivestym", "active_ingredients": [{"name": "FILGRASTIM", "strength": "480 ug/1.6mL"}], "application_number": "BLA761080", "marketing_category": "BLA", "marketing_start_date": "20190311", "listing_expiration_date": "20261231"}