bleomycin

Generic: bleomycin sulfate

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

Drug Facts

Product Profile

Brand Name bleomycin
Generic Name bleomycin sulfate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR INTRAPLEURAL INTRAVENOUS SUBCUTANEOUS
Active Ingredients

bleomycin sulfate 30 [USP'U]/1

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-137
Product ID 63323-137_93aba071-101f-4610-90fa-27e3635b2c1c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065185
Listing Expiration 2026-12-31
Marketing Start 2009-02-13

Pharmacologic Class

Classes
cytoprotective agent [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323137
Hyphenated Format 63323-137

Supplemental Identifiers

RxCUI
1726673 1726676
UNII
7DP3NTV15T

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 bleomycin (source: ndc)
Generic Name bleomycin sulfate (source: ndc)
Application Number ANDA065185 (source: ndc)
Routes
INTRAMUSCULAR INTRAPLEURAL INTRAVENOUS SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 30 [USP'U]/1
source: ndc
Packaging
  • 1 VIAL in 1 CARTON (63323-137-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL
source: ndc

Packages (1)

63323-137-20 1 VIAL in 1 CARTON (63323-137-20) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL

Ingredients (1)

bleomycin sulfate (30 [USP'U]/1)

Linked Drug Pages (1)

Bleomycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAPLEURAL", "INTRAVENOUS", "SUBCUTANEOUS"], "spl_id": "93aba071-101f-4610-90fa-27e3635b2c1c", "openfda": {"unii": ["7DP3NTV15T"], "rxcui": ["1726673", "1726676"], "spl_set_id": ["b5806c40-12ce-48e3-8abd-9f8997ef4428"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL in 1 CARTON (63323-137-20)  / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL", "package_ndc": "63323-137-20", "marketing_start_date": "20090213"}], "brand_name": "Bleomycin", "product_id": "63323-137_93aba071-101f-4610-90fa-27e3635b2c1c", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Cytoprotective Agent [EPC]"], "product_ndc": "63323-137", "generic_name": "BLEOMYCIN SULFATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Bleomycin", "active_ingredients": [{"name": "BLEOMYCIN SULFATE", "strength": "30 [USP'U]/1"}], "application_number": "ANDA065185", "marketing_category": "ANDA", "marketing_start_date": "20090213", "listing_expiration_date": "20261231"}