NDC 66220-110

Totect

Dexrazoxane Hydrochloride

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

• Product ID: 66220-110_894e73f5-45a7-4d69-adee-181cfd379d49
• NDC: 66220-110
• 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: 2017-07-25
• Marketing Category: NDA / NDA
• Application Number: NDA022025
• Labeler Name: Cumberland Pharmaceuticals Inc.
• Substance Name: DEXRAZOXANE HYDROCHLORIDE
• Active Ingredient Strength: 500 mg/1
• Pharm Classes: Cytoprotective Agent [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 66220-110-01

1 VIAL, SINGLE-USE in 1 CARTON (66220-110-01) > 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-USE

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

NDC SPL Data Element Entries

NDC 66220-110-01 [66220011001]

Totect INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA022025
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-07-25
• Marketing End Date: 2020-10-30

Drug Details

Active Ingredients

Ingredient	Strength
DEXRAZOXANE HYDROCHLORIDE	500 mg/1

OpenFDA Data

• SPL SET ID: 42389568-7a87-4237-839f-fbdc1264351a
• Manufacturer:
  • Cumberland Pharmaceuticals Inc.
• UNII:
  • 5346058Q7S
• RxNorm Concept Unique ID - RxCUI:
  • 1736590
  • 1939308

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