NDC 59676-966

Doxorubicin Hydrochloride liposome

Doxorubicin Hydrochloride

Doxorubicin Hydrochloride liposome is a Intravenous Injection, Suspension, Liposomal in the Human Prescription Drug category. It is labeled and distributed by Janssen Products, Lp. The primary component is Doxorubicin Hydrochloride.

• Product ID: 59676-966_1b735fad-4913-43bf-a73c-5fc1efa6cf46
• NDC: 59676-966
• Product Type: Human Prescription Drug
• Proprietary Name: Doxorubicin Hydrochloride liposome
• Generic Name: Doxorubicin Hydrochloride
• Dosage Form: Injection, Suspension, Liposomal
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-06-26
• Marketing End Date: 2020-10-31
• Marketing Category: NDA / NDA
• Application Number: NDA050718
• Labeler Name: Janssen Products, LP
• Substance Name: DOXORUBICIN HYDROCHLORIDE
• Active Ingredient Strength: 2 mg/mL
• Pharm Classes: Anthracycline Topoisomerase Inhibitor [EPC],Anthracyclines [CS],Topoisomerase Inhibitors [MoA]
• NDC Exclude Flag: N

Packaging

NDC 59676-966-01

1 VIAL in 1 CARTON (59676-966-01) > 10 mL in 1 VIAL

• Marketing Start Date: 2017-06-26
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59676-966-01 [59676096601]

Doxorubicin Hydrochloride liposome INJECTION, SUSPENSION, LIPOSOMAL

• Marketing Category: NDA
• Application Number: NDA050718
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-06-26
• Marketing End Date: 2020-09-30

NDC 59676-966-02 [59676096602]

Doxorubicin Hydrochloride liposome INJECTION, SUSPENSION, LIPOSOMAL

• Marketing Category: NDA
• Application Number: NDA050718
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2017-06-26
• Marketing End Date: 2020-10-31

Drug Details

Active Ingredients

Ingredient	Strength
DOXORUBICIN HYDROCHLORIDE	2 mg/mL

OpenFDA Data

• SPL SET ID: ce69f195-76fc-4c95-869e-14ea9a076655
• Manufacturer:
  • Janssen Products, LP
• UNII:
  • 82F2G7BL4E
• RxNorm Concept Unique ID - RxCUI:
  • 1790127
  • 1790115

Pharmacological Class

• Anthracycline Topoisomerase Inhibitor [EPC]
• Anthracyclines [CS]
• Topoisomerase Inhibitors [MoA]

NDC Crossover Matching brand name "Doxorubicin Hydrochloride liposome" or generic name "Doxorubicin Hydrochloride"

NDC	Brand Name	Generic Name
59676-966	Doxorubicin Hydrochloride liposome	Doxorubicin Hydrochloride liposome
0338-0080	Doxorubicin Hydrochloride Liposome	Doxorubicin Hydrochloride Liposome
0338-0086	Doxorubicin Hydrochloride Liposome	Doxorubicin Hydrochloride Liposome
0069-3030	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride
0069-3031	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride
0069-3032	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride
0069-3033	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride
0069-3034	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride
0069-4004	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride
0069-4015	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride
0069-4026	Doxorubicin Hydrochloride	Doxorubicin Hydrochloride