NDC 21695-367

EPIVIR

Lamivudine

EPIVIR is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp. The primary component is Lamivudine.

• Product ID: 21695-367_166abd26-675e-4832-9d18-0567f2a9d4e4
• NDC: 21695-367
• Product Type: Human Prescription Drug
• Proprietary Name: EPIVIR
• Generic Name: Lamivudine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 1995-11-21
• Marketing Category: NDA / NDA
• Application Number: NDA020564
• Labeler Name: Rebel Distributors Corp
• Substance Name: LAMIVUDINE
• Active Ingredient Strength: 150 mg/1
• Pharm Classes: Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 21695-367-06

6 TABLET, FILM COATED in 1 BOTTLE (21695-367-06)

• Marketing Start Date: 1995-11-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 21695-367-06 [21695036706]

EPIVIR TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020564
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1995-11-21
• Inactivation Date: 2019-09-24

Drug Details

Active Ingredients

Ingredient	Strength
LAMIVUDINE	150 mg/1

OpenFDA Data

• SPL SET ID: 166abd26-675e-4832-9d18-0567f2a9d4e4
• Manufacturer:
  • Rebel Distributors Corp
• UNII:
  • 2T8Q726O95
• RxNorm Concept Unique ID - RxCUI:
  • 199147
  • 152931

Pharmacological Class

• Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]
• Nucleoside Analog [EXT]
• Nucleoside Reverse Transcriptase Inhibitors [MoA]

NDC Crossover Matching brand name "EPIVIR" or generic name "Lamivudine"

NDC	Brand Name	Generic Name
0173-0662	EPIVIR	lamivudine
0173-0663	EPIVIR	lamivudine
21695-367	EPIVIR	lamivudine
49702-203	EPIVIR	lamivudine
49702-204	EPIVIR	lamivudine
49702-205	EPIVIR	lamivudine
50090-0550	EPIVIR	lamivudine
53808-0245	EPIVIR	EPIVIR
53808-0246	EPIVIR	EPIVIR
0904-6583	LAMIVUDINE	lamivudine
10135-605	Lamivudine	Lamivudine
31722-001	lamivudine	lamivudine
31722-752	Lamivudine	Lamivudine
31722-753	Lamivudine	Lamivudine
31722-754	Lamivudine	Lamivudine
33342-001	Lamivudine	Lamivudine
33342-002	Lamivudine	Lamivudine