NDC 53808-0245

EPIVIR

Lamivudine

EPIVIR is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by State Of Florida Doh Central Pharmacy. The primary component is Lamivudine.

• Product ID: 53808-0245_4e2ee289-a8d8-4d02-ac27-0a2a2d0bbe22
• NDC: 53808-0245
• Product Type: Human Prescription Drug
• Proprietary Name: EPIVIR
• Generic Name: Lamivudine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2009-07-01
• Marketing Category: NDA / NDA
• Application Number: NDA020564
• Labeler Name: State of Florida DOH Central Pharmacy
• 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 53808-0245-1

30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0245-1)

• Marketing Start Date: 2009-07-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53808-0245-1 [53808024501]

EPIVIR TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA020564
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2009-07-01
• Inactivation Date: 2019-10-21

Drug Details

Active Ingredients

Ingredient	Strength
LAMIVUDINE	150 mg/1

OpenFDA Data

• SPL SET ID: 13ca868d-a734-4c2f-88f0-ac1071ba7311
• Manufacturer:
  • State of Florida DOH Central Pharmacy
• UNII:
  • 2T8Q726O95
• RxNorm Concept Unique ID - RxCUI:
  • 199147
  • 352230
  • 349491
  • 152931
• UPC Code:
  • 0301730714008
  • 0301730470010

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