NDC 0338-0086

Doxorubicin Hydrochloride Liposome

Doxorubicin Hydrochloride Liposome

Doxorubicin Hydrochloride Liposome is a Intravenous Injection, Suspension, Liposomal in the Human Prescription Drug category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is Doxorubicin Hydrochloride.

• Product ID: 0338-0086_1bbcb035-47b4-4a83-abf6-74c33725d3ec
• NDC: 0338-0086
• Product Type: Human Prescription Drug
• Proprietary Name: Doxorubicin Hydrochloride Liposome
• Generic Name: Doxorubicin Hydrochloride Liposome
• Dosage Form: Injection, Suspension, Liposomal
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-08-15
• Marketing Category: NDA / NDA
• Application Number: NDA050718
• Labeler Name: Baxter Healthcare Corporation
• 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: 2021-12-31

Packaging

NDC 0338-0086-01

1 VIAL, SINGLE-USE in 1 CARTON (0338-0086-01) > 25 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2019-08-15
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0338-0086-01 [00338008601]

Doxorubicin Hydrochloride Liposome INJECTION, SUSPENSION, LIPOSOMAL

• Marketing Category: NDA
• Application Number: NDA050718
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-08-15

Drug Details

Active Ingredients

Ingredient	Strength
DOXORUBICIN HYDROCHLORIDE	2 mg/mL

OpenFDA Data

• SPL SET ID: cf25a018-e795-49e4-8533-a581f8366dd9
• Manufacturer:
  • Baxter Healthcare Corporation
• 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 Liposome"

NDC	Brand Name	Generic Name
0338-0080	Doxorubicin Hydrochloride Liposome	Doxorubicin Hydrochloride Liposome
0338-0086	Doxorubicin Hydrochloride Liposome	Doxorubicin Hydrochloride Liposome
59676-966	Doxorubicin Hydrochloride liposome	doxorubicin hydrochloride