NDC 0013-8717

Zinecard

Dexrazoxane

Zinecard is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmacia And Upjohn Company Llc. The primary component is Dexrazoxane Hydrochloride.

• Product ID: 0013-8717_44866db3-8132-4de9-a006-5e350fdb5e9e
• NDC: 0013-8717
• Product Type: Human Prescription Drug
• Proprietary Name: Zinecard
• Generic Name: Dexrazoxane
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1995-05-26
• Marketing Category: NDA / NDA
• Application Number: NDA020212
• Labeler Name: Pharmacia and Upjohn Company LLC
• Substance Name: DEXRAZOXANE HYDROCHLORIDE
• Active Ingredient Strength: 250 mg/25mL
• Pharm Classes: Cytoprotective Agent [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0013-8717-62

1 VIAL, SINGLE-DOSE in 1 CARTON (0013-8717-62) > 25 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 1995-05-26
• Marketing End Date: 2021-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0013-8717-62 [00013871762]

Zinecard INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020212
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1995-05-26

Drug Details

Active Ingredients

Ingredient	Strength
DEXRAZOXANE HYDROCHLORIDE	250 mg/25mL

OpenFDA Data

• SPL SET ID: f68a34ae-e17e-45b3-8c8e-8d7194b2124a
• Manufacturer:
  • Pharmacia and Upjohn Company LLC
• UNII:
  • 5346058Q7S
• RxNorm Concept Unique ID - RxCUI:
  • 1736590
  • 1736592
  • 1736588
  • 1736585

Pharmacological Class

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

NDC Crossover Matching brand name "Zinecard" or generic name "Dexrazoxane"

NDC	Brand Name	Generic Name
0013-8717	Zinecard	dexrazoxane
0013-8727	Zinecard	dexrazoxane
76310-002	Cardioxane	dexrazoxane
0143-9247	Dexrazoxane	Dexrazoxane
0143-9248	Dexrazoxane	Dexrazoxane
55150-434	DEXRAZOXANE	DEXRAZOXANE
55150-437	DEXRAZOXANE	DEXRAZOXANE
67457-207	Dexrazoxane Hydrochloride	dexrazoxane
67457-208	Dexrazoxane Hydrochloride	dexrazoxane