NDC 76310-110

Totect

Dexrazoxane Hydrochloride

Totect is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Clinigen Group Plc. The primary component is Dexrazoxane Hydrochloride.

• Product ID: 76310-110_18b36bd6-7536-458c-af19-caa628dbbb3f
• NDC: 76310-110
• Product Type: Human Prescription Drug
• Proprietary Name: Totect
• Generic Name: Dexrazoxane Hydrochloride
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2020-01-01
• Marketing End Date: 2022-11-30
• Marketing Category: NDA / NDA
• Application Number: NDA022025
• Labeler Name: CLINIGEN GROUP PLC
• Substance Name: DEXRAZOXANE HYDROCHLORIDE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Cytoprotective Agent [EPC]
• NDC Exclude Flag: N

Packaging

NDC 76310-110-01

1 VIAL, SINGLE-USE in 1 CARTON (76310-110-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2020-01-01
• Marketing End Date: 2022-11-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76310-110-01 [76310011001]

Totect INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA022025
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-01-01

Drug Details

Active Ingredients

Ingredient	Strength
DEXRAZOXANE HYDROCHLORIDE	500 mg/1

Pharmacological Class

• Cytoprotective Agent [EPC]

NDC Crossover Matching brand name "Totect" or generic name "Dexrazoxane Hydrochloride"

NDC	Brand Name	Generic Name
66220-110	Totect	dexrazoxane hydrochloride
76310-110	Totect	dexrazoxane hydrochloride
51991-942	Dexrazoxane	Dexrazoxane Hydrochloride