NDC 69448-003

MUTAMYCIN

Mitomycin

MUTAMYCIN is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Accord Biopharma Inc.. The primary component is Mitomycin.

• Product ID: 69448-003_55ab68d0-c46a-2f41-e054-00144ff88e88
• NDC: 69448-003
• Product Type: Human Prescription Drug
• Proprietary Name: MUTAMYCIN
• Generic Name: Mitomycin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-07-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA064144
• Labeler Name: Accord BioPharma Inc.
• Substance Name: MITOMYCIN
• Active Ingredient Strength: 40 mg/80mL
• Pharm Classes: Alkylating Activity [MoA],Alkylating Drug [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 69448-003-38

1 VIAL in 1 BOX, UNIT-DOSE (69448-003-38) > 80 mL in 1 VIAL

• Marketing Start Date: 2017-07-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 69448-003-38 [69448000338]

MUTAMYCIN INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA064144
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-07-25

Drug Details

Active Ingredients

Ingredient	Strength
MITOMYCIN	40 mg/80mL

OpenFDA Data

• SPL SET ID: cbf0f6ba-3a53-4791-9a85-5c6b271eeb8e
• Manufacturer:
  • Accord BioPharma Inc.
• UNII:
  • 50SG953SK6
• RxNorm Concept Unique ID - RxCUI:
  • 1740898
  • 1740894
  • 1812484
  • 1812480
  • 1740900
  • 1812482
• UPC Code:
  • 0369448002114
  • 0369448001056

Pharmacological Class

• Alkylating Activity [MoA]
• Alkylating Drug [EPC]
• Alkylating Activity [MoA]
• Alkylating Drug [EPC]

NDC Crossover Matching brand name "MUTAMYCIN" or generic name "Mitomycin"

NDC	Brand Name	Generic Name
69448-001	MUTAMYCIN	Mitomycin
69448-002	MUTAMYCIN	Mitomycin
69448-003	MUTAMYCIN	Mitomycin
69605-103	JELMYTO	mitomycin
0143-9135	Mitomycin	Mitomycin
0143-9136	Mitomycin	Mitomycin
0143-9279	Mitomycin	Mitomycin
0143-9280	Mitomycin	Mitomycin
16729-108	Mitomycin	Mitomycin
16729-115	Mitomycin	Mitomycin
16729-116	Mitomycin	Mitomycin
16729-246	Mitomycin	Mitomycin
16729-247	Mitomycin	Mitomycin
16729-248	Mitomycin	Mitomycin
67457-518	Mitomycin	Mitomycin
67457-519	Mitomycin	Mitomycin
67457-520	Mitomycin	Mitomycin
67457-995	Mitomycin	Mitomycin
67457-996	Mitomycin	Mitomycin
67457-997	Mitomycin	Mitomycin
68001-389	Mitomycin	Mitomycin
68001-390	Mitomycin	Mitomycin
68001-391	Mitomycin	Mitomycin
68083-483	MITOMYCIN	MITOMYCIN
68083-484	MITOMYCIN	MITOMYCIN
68083-502	MITOMYCIN	MITOMYCIN
71288-137	MITOMYCIN	MITOMYCIN
71288-138	MITOMYCIN	MITOMYCIN
49771-002	Mitosol	mitomycin