fulphila

Generic: pegfilgrastim-jmdb

Labeler: biocon biologics inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name fulphila
Generic Name pegfilgrastim-jmdb
Labeler biocon biologics inc.
Dosage Form INJECTION
Routes
SUBCUTANEOUS
Active Ingredients

pegfilgrastim 6 mg/.6mL

Manufacturer
Biocon Biologics Inc.

Identifiers & Regulatory

Product NDC 83257-005
Product ID 83257-005_9c225ff4-d153-535d-98c2-7b2eaec81e12
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761075
Listing Expiration 2026-12-31
Marketing Start 2023-10-01

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 83257005
Hyphenated Format 83257-005

Supplemental Identifiers

RxCUI
2048020 2048025
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 fulphila (source: ndc)
Generic Name pegfilgrastim-jmdb (source: ndc)
Application Number BLA761075 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 6 mg/.6mL
source: ndc
Packaging
  • 1 SYRINGE in 1 CARTON (83257-005-41) / .6 mL in 1 SYRINGE
source: ndc

Packages (1)

83257-005-41 1 SYRINGE in 1 CARTON (83257-005-41) / .6 mL in 1 SYRINGE

Ingredients (1)

pegfilgrastim (6 mg/.6mL)

Linked Drug Pages (1)

Fulphila ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "9c225ff4-d153-535d-98c2-7b2eaec81e12", "openfda": {"nui": ["M0024696", "N0000009451", "N0000175666"], "unii": ["3A58010674"], "rxcui": ["2048020", "2048025"], "spl_set_id": ["9bfc4d3e-6120-7fec-f1d6-0b3743752034"], "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": ["Biocon Biologics Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 SYRINGE in 1 CARTON (83257-005-41)  / .6 mL in 1 SYRINGE", "package_ndc": "83257-005-41", "marketing_start_date": "20231001"}], "brand_name": "Fulphila", "product_id": "83257-005_9c225ff4-d153-535d-98c2-7b2eaec81e12", "dosage_form": "INJECTION", "pharm_class": ["Granulocyte Colony-Stimulating Factor [CS]", "Increased Myeloid Cell Production [PE]", "Leukocyte Growth Factor [EPC]"], "product_ndc": "83257-005", "generic_name": "pegfilgrastim-jmdb", "labeler_name": "Biocon Biologics Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fulphila", "active_ingredients": [{"name": "PEGFILGRASTIM", "strength": "6 mg/.6mL"}], "application_number": "BLA761075", "marketing_category": "BLA", "marketing_start_date": "20231001", "listing_expiration_date": "20261231"}