NDC 67457-928

Dactinomycin

Dactinomycin

Dactinomycin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Dactinomycin.

• Product ID: 67457-928_0e173ef5-d0f1-41c3-9b64-543195443310
• NDC: 67457-928
• Product Type: Human Prescription Drug
• Proprietary Name: Dactinomycin
• Generic Name: Dactinomycin
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-11-09
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203385
• Labeler Name: Mylan Institutional LLC
• 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: 2020-12-31

Packaging

NDC 67457-928-02

1 VIAL, SINGLE-DOSE in 1 CARTON (67457-928-02) > 1 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2019-06-20
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-928-02 [67457092802]

Dactinomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA203385
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-20

Drug Details

Active Ingredients

Ingredient	Strength
DACTINOMYCIN	.5 mg/mL

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
55292-811	Cosmegen	dactinomycin