NDC 71288-107

Bleomycin

Bleomycin Sulfate

Bleomycin is a Intramuscular; Intrapleural; Intravenous; Subcutaneous Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Meitheal Pharmaceuticals Inc.. The primary component is Bleomycin Sulfate.

• Product ID: 71288-107_ae0d7fba-937e-42d1-b7f5-ae6f7b860bc4
• NDC: 71288-107
• Product Type: Human Prescription Drug
• Proprietary Name: Bleomycin
• Generic Name: Bleomycin Sulfate
• Dosage Form: Powder, For Solution
• Route of Administration: INTRAMUSCULAR; INTRAPLEURAL; INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 2018-08-31
• Marketing Category: ANDA / ANDA
• Application Number: ANDA205030
• Labeler Name: Meitheal Pharmaceuticals Inc.
• Substance Name: BLEOMYCIN SULFATE
• Active Ingredient Strength: 30 [USP'U]/1
• Pharm Classes: Cytoprotective Agent [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 71288-107-20

1 VIAL, SINGLE-DOSE in 1 CARTON (71288-107-20) > 30 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2018-08-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71288-107-20 [71288010720]

Bleomycin POWDER, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA205030
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-08-31

Drug Details

Active Ingredients

Ingredient	Strength
BLEOMYCIN SULFATE	30 [USP'U]/1

OpenFDA Data

• SPL SET ID: 640602f9-a7df-46f0-a9b1-19c471008bee
• Manufacturer:
  • Meitheal Pharmaceuticals Inc.
• UNII:
  • 7DP3NTV15T
• RxNorm Concept Unique ID - RxCUI:
  • 1726676
  • 1726673

Pharmacological Class

• Cytoprotective Agent [EPC]
• Cytoprotective Agent [EPC]

NDC Crossover Matching brand name "Bleomycin" or generic name "Bleomycin Sulfate"

NDC	Brand Name	Generic Name
0143-9240	Bleomycin	Bleomycin
0143-9241	Bleomycin	Bleomycin
0409-0323	Bleomycin	BLEOMYCIN
0409-0332	Bleomycin	BLEOMYCIN
0703-3154	Bleomycin	Bleomycin
0703-3155	Bleomycin	Bleomycin
16714-886	Bleomycin	Bleomycin
16714-908	Bleomycin	Bleomycin
61703-323	Bleomycin	BLEOMYCIN
61703-332	Bleomycin	BLEOMYCIN
63323-136	Bleomycin	BLEOMYCIN SULFATE
63323-137	Bleomycin	BLEOMYCIN SULFATE
69097-364	Bleomycin	Bleomycin
70121-1567	Bleomycin	Bleomycin
71288-106	Bleomycin	Bleomycin Sulfate
71288-107	Bleomycin	Bleomycin Sulfate