NDC 53808-0893

EPIVIR HBV

Lamivudine

EPIVIR HBV 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: 53808-0893_50cf8e19-72f4-4202-895f-cc9f81c2ca6f
• NDC: 53808-0893
• Product Type: Human Prescription Drug
• Proprietary Name: EPIVIR HBV
• Generic Name: Lamivudine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2014-01-01
• Marketing Category: NDA / NDA
• Application Number: NDA021003
• Labeler Name: State of Florida DOH Central Pharmacy
• Substance Name: LAMIVUDINE
• Active Ingredient Strength: 100 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: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 53808-0893-1

30 TABLET, FILM COATED in 1 BLISTER PACK (53808-0893-1)

• Marketing Start Date: 2014-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53808-0893-1 [53808089301]

EPIVIR HBV TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021003
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-01-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
LAMIVUDINE	100 mg/1

OpenFDA Data

• SPL SET ID: 83009c27-f54b-47df-b8b2-e2e4e0b8f4e8
• Manufacturer:
  • State of Florida DOH Central Pharmacy
• UNII:
  • 2T8Q726O95
• RxNorm Concept Unique ID - RxCUI:
  • 213483
  • 205328

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 HBV" or generic name "Lamivudine"

NDC	Brand Name	Generic Name
53808-0893	EPIVIR HBV	EPIVIR HBV
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
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