NDC 55292-811

Cosmegen

Dactinomycin

Cosmegen is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Recordati Rare Diseases, Inc.. The primary component is Dactinomycin.

• Product ID: 55292-811_137c07d7-e2bf-4f59-8b8f-4ebe119e576d
• NDC: 55292-811
• Product Type: Human Prescription Drug
• Proprietary Name: Cosmegen
• Generic Name: Dactinomycin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1964-12-10
• Marketing Category: NDA / NDA
• Application Number: NDA050682
• Labeler Name: RECORDATI RARE DISEASES, INC.
• Substance Name: DACTINOMYCIN
• Active Ingredient Strength: 1 mg/mL
• Pharm Classes: Actinomycin [EPC],Nucleic Acid Synthesis Inhibitors [MoA],Protein Synthesis Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 55292-811-55

12 VIAL, SINGLE-DOSE in 1 CARTON (55292-811-55) > 1 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 1964-12-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55292-811-55 [55292081155]

Cosmegen INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA050682
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1964-12-10

Drug Details

Active Ingredients

Ingredient	Strength
DACTINOMYCIN	.5 mg/mL

OpenFDA Data

• SPL SET ID: 9914e793-a49c-eb00-1ab7-f606c786fe25
• Manufacturer:
  • RECORDATI RARE DISEASES, INC.
• UNII:
  • 1CC1JFE158
• RxNorm Concept Unique ID - RxCUI:
  • 105569
  • 239179

Pharmacological Class

• Actinomycin [EPC]
• Nucleic Acid Synthesis Inhibitors [MoA]
• Protein Synthesis Inhibitors [MoA]
• Actinomycin [EPC]
• Nucleic Acid Synthesis Inhibitors [MoA]
• Protein Synthesis Inhibitors [MoA]

NDC Crossover Matching brand name "Cosmegen" or generic name "Dactinomycin"

NDC	Brand Name	Generic Name
55292-811	Cosmegen	dactinomycin
39822-2100	dactinomycin	dactinomycin
42658-008	Dactinomycin	dactinomycin
55150-431	DACTINOMYCIN	DACTINOMYCIN
55150-928	DACTINOMYCIN	DACTINOMYCIN
66993-489	Dactinomycin	Dactinomycin
67457-513	Dactinomycin	Dactinomycin
67457-928	Dactinomycin	Dactinomycin
71288-129	Dactinomycin	Dactinomycin