NDC 59676-960

DOXIL

Doxorubicin Hydrochloride

DOXIL 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: 59676-960_17206b15-725c-410d-838d-ccb228c6ea2b
• NDC: 59676-960
• Product Type: Human Prescription Drug
• Proprietary Name: DOXIL
• Generic Name: Doxorubicin Hydrochloride
• Dosage Form: Injection, Suspension, Liposomal
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 1995-11-17
• 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
• Listing Certified Through: 2019-12-31

Packaging

NDC 59676-960-02

1 VIAL, SINGLE-USE in 1 CARTON (59676-960-02) > 25 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 1995-11-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 59676-960-02 [59676096002]

DOXIL INJECTION, SUSPENSION, LIPOSOMAL

• Marketing Category: NDA
• Application Number: NDA050718
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1995-11-17
• Marketing End Date: 2020-06-30

NDC 59676-960-01 [59676096001]

DOXIL INJECTION, SUSPENSION, LIPOSOMAL

• Marketing Category: NDA
• Application Number: NDA050718
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1995-11-17
• Marketing End Date: 2020-09-30

Drug Details

Active Ingredients

Ingredient	Strength
DOXORUBICIN HYDROCHLORIDE	2 mg/mL

OpenFDA Data

• SPL SET ID: 21d9c619-7e94-49e2-ac41-31e9ea96554a
• Manufacturer:
  • Janssen Products, LP
• UNII:
  • 82F2G7BL4E
• RxNorm Concept Unique ID - RxCUI:
  • 1790127
  • 1790131
  • 1790115
  • 1790128

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
59676-960	DOXIL	DOXIL
0338-0063	DOXIL	DOXIL
0338-0067	DOXIL	DOXIL
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