abacavir and lamivudine (65862-335)

Drug Facts

Product Profile

Brand Name abacavir and lamivudine

Generic Name abacavir and lamivudine

Labeler aurobindo pharma limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

abacavir sulfate 600 mg/1, lamivudine 300 mg/1

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-335

Product ID 65862-335_7fbb109d-29d0-4439-b4ef-00c587cc6099

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090159

Listing Expiration 2026-12-31

Marketing Start 2018-11-15

Pharmacologic Class

Established (EPC)

hepatitis b virus nucleoside analog reverse transcriptase inhibitor [epc] human immunodeficiency virus nucleoside analog reverse transcriptase inhibitor [epc]

Mechanism of Action

nucleoside reverse transcriptase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65862335

Hyphenated Format 65862-335

Supplemental Identifiers

RxCUI

602393

UNII

J220T4J9Q2 2T8Q726O95

NUI

N0000175656 N0000175462 N0000009947

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name abacavir and lamivudine (source: ndc)

Generic Name abacavir and lamivudine (source: ndc)

Application Number ANDA090159 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

600 mg/1
300 mg/1

source: ndc

Packaging

10 BLISTER PACK in 1 CARTON (65862-335-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
1 BOTTLE in 1 CARTON (65862-335-30) / 30 TABLET, FILM COATED in 1 BOTTLE

source: ndc

Packages (2)

65862-335-10 10 BLISTER PACK in 1 CARTON (65862-335-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 65862-335-30 1 BOTTLE in 1 CARTON (65862-335-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Ingredients (2)

abacavir sulfate (600 mg/1) lamivudine (300 mg/1)

Linked Drug Pages (1)

Abacavir and Lamivudine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "7fbb109d-29d0-4439-b4ef-00c587cc6099", "openfda": {"nui": ["N0000175656", "N0000175462", "N0000009947"], "unii": ["J220T4J9Q2", "2T8Q726O95"], "rxcui": ["602393"], "spl_set_id": ["deda1a24-2f51-4601-9881-347f47270940"], "pharm_class_epc": ["Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]"], "pharm_class_moa": ["Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 BLISTER PACK in 1 CARTON (65862-335-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-335-10", "marketing_start_date": "20181115"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (65862-335-30)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "65862-335-30", "marketing_start_date": "20181115"}], "brand_name": "Abacavir and Lamivudine", "product_id": "65862-335_7fbb109d-29d0-4439-b4ef-00c587cc6099", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 1A1 Inhibitors [MoA]", "Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "65862-335", "generic_name": "Abacavir and Lamivudine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Abacavir and Lamivudine", "active_ingredients": [{"name": "ABACAVIR SULFATE", "strength": "600 mg/1"}, {"name": "LAMIVUDINE", "strength": "300 mg/1"}], "application_number": "ANDA090159", "marketing_category": "ANDA", "marketing_start_date": "20181115", "listing_expiration_date": "20261231"}