NDC 70518-0691

EPZICOM

Abacavir Sulfate And Lamivudine

EPZICOM is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Abacavir Sulfate; Lamivudine.

• Product ID: 70518-0691_574f48d8-fd97-553f-e053-2a91aa0a2a7d
• NDC: 70518-0691
• Product Type: Human Prescription Drug
• Proprietary Name: EPZICOM
• Generic Name: Abacavir Sulfate And Lamivudine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2017-08-17
• Marketing Category: NDA / NDA
• Application Number: NDA021652
• Labeler Name: REMEDYREPACK INC.
• Substance Name: ABACAVIR SULFATE; LAMIVUDINE
• Active Ingredient Strength: 600 mg/1; 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],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA]
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 70518-0691-0

30 TABLET, FILM COATED in 1 BLISTER PACK (70518-0691-0)

• Marketing Start Date: 2017-08-17
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70518-0691-0 [70518069100]

EPZICOM TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA021652
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2017-08-17
• Marketing End Date: 2020-05-01

Drug Details

Active Ingredients

Ingredient	Strength
ABACAVIR SULFATE	600 mg/1

OpenFDA Data

• SPL SET ID: 8c6b1125-0ed7-4cb6-b0ad-6ac63dbb4109
• Manufacturer:
  • REMEDYREPACK INC.
• UNII:
  • J220T4J9Q2
  • 2T8Q726O95
• RxNorm Concept Unique ID - RxCUI:
  • 602393
  • 602395

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

NDC Crossover Matching brand name "EPZICOM" or generic name "Abacavir Sulfate And Lamivudine"

NDC	Brand Name	Generic Name
49349-701	Epzicom	Abacavir Sulfate and Lamivudine
49702-206	EPZICOM	abacavir sulfate and lamivudine
50090-0874	EPZICOM	abacavir sulfate and lamivudine
53808-0767	EPZICOM	abacavir sulfate and lamivudine
70518-0691	EPZICOM	abacavir sulfate and lamivudine
66993-482	Abacavir and Lamivudine	abacavir sulfate and lamivudine