stimufend

Generic: pegflilgrastim-fpgk

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name stimufend
Generic Name pegflilgrastim-fpgk
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

pegfilgrastim 6 mg/.6mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-371
Product ID 65219-371_90fa8a88-1bd6-49cf-a482-ccbc0d315b3d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761173
Listing Expiration 2026-12-31
Marketing Start 2022-10-06

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 65219371
Hyphenated Format 65219-371

Supplemental Identifiers

RxCUI
2613763 2613769
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 stimufend (source: ndc)
Generic Name pegflilgrastim-fpgk (source: ndc)
Application Number BLA761173 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/.6mL
source: ndc
Packaging
  • 1 BLISTER PACK in 1 CARTON (65219-371-10) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE
source: ndc

Packages (1)

65219-371-10 1 BLISTER PACK in 1 CARTON (65219-371-10) / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE

Ingredients (1)

pegfilgrastim (6 mg/.6mL)

Linked Drug Pages (1)

STIMUFEND ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "90fa8a88-1bd6-49cf-a482-ccbc0d315b3d", "openfda": {"nui": ["M0024696", "N0000009451", "N0000175666"], "unii": ["3A58010674"], "rxcui": ["2613763", "2613769"], "spl_set_id": ["b44bcb82-7e60-4dab-a658-115bdf5c053c"], "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": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BLISTER PACK in 1 CARTON (65219-371-10)  / 1 SYRINGE in 1 BLISTER PACK / .6 mL in 1 SYRINGE", "package_ndc": "65219-371-10", "marketing_start_date": "20221006"}], "brand_name": "STIMUFEND", "product_id": "65219-371_90fa8a88-1bd6-49cf-a482-ccbc0d315b3d", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Granulocyte Colony-Stimulating Factor [CS]", "Granulocyte-Macrophage Colony-Stimulating Factor [CS]", "Increased Myeloid Cell Production [PE]", "Leukocyte Growth Factor [EPC]"], "product_ndc": "65219-371", "generic_name": "pegflilgrastim-fpgk", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "STIMUFEND", "active_ingredients": [{"name": "PEGFILGRASTIM", "strength": "6 mg/.6mL"}], "application_number": "BLA761173", "marketing_category": "BLA", "marketing_start_date": "20221006", "listing_expiration_date": "20261231"}