Bleomycin
Bleomycin for Injection, USP
Approved
Approval ID
e629ba5a-4e08-4249-9551-af6dbd98a7e4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 25, 2022
Manufacturers
FDA
Hospira, Inc.
DUNS: 141588017
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
BLEOMYCIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-0332
Application NumberANDA065031
Product Classification
M
Marketing Category
C73584
G
Generic Name
BLEOMYCIN
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAPLEURAL
Effective DateAugust 25, 2022
FDA Product Classification
INGREDIENTS (3)
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
BLEOMYCIN SULFATEActive
Quantity: 15 [USP'U] in 1 1
Code: 7DP3NTV15T
Classification: ACTIM
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BLEOMYCIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0409-0323
Application NumberANDA065031
Product Classification
M
Marketing Category
C73584
G
Generic Name
BLEOMYCIN
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAPLEURAL
Effective DateAugust 25, 2022
FDA Product Classification
INGREDIENTS (3)
BLEOMYCIN SULFATEActive
Quantity: 30 [USP'U] in 1 1
Code: 7DP3NTV15T
Classification: ACTIM
SULFURIC ACIDInactive
Code: O40UQP6WCF
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT