abacavir and lamivudine (68180-288)

Drug Facts

Product Profile

Brand Name abacavir and lamivudine

Generic Name abacavir and lamivudine

Labeler lupin pharmaceuticals, inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

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

Manufacturer

Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-288

Product ID 68180-288_61b0304c-2258-40ed-9fc8-bc363b0906f6

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA204990

Listing Expiration 2026-12-31

Marketing Start 2017-03-28

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 68180288

Hyphenated Format 68180-288

Supplemental Identifiers

RxCUI

602393

UPC

0368180288060

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 ANDA204990 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

600 mg/1
300 mg/1

source: ndc

Packaging

16 HOW SUPPLIED/STORAGE AND HANDLING Abacavir and lamivudine tablets USP are available as tablets. Each tablet contains 600 mg of abacavir as abacavir sulfate and 300 mg of lamivudine. The tablets are orange colored, oval shaped, biconvex, film-coated tablets debossed with "LU" on one side "C51" on the other side. They are packaged as follows: Bottles (120cc) of 30 Tablets (NDC 68180-288-06). Bottles (250cc) of 90 Tablets (NDC 68180-288-09). Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Abacavir and Lamivudine Tablets USP Rx Only 600 mg and 300 mg NDC 68180-288-06 30 Tablets Abacavir and Lamivudine Tablets USP Rx Only 600 mg and 300 mg NDC 68180-288-06 30 Tablets image-01 image-02

source: label

Packages (0)

No package records.

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": "61b0304c-2258-40ed-9fc8-bc363b0906f6", "openfda": {"nui": ["N0000175656", "N0000175462", "N0000009947"], "upc": ["0368180288060"], "unii": ["J220T4J9Q2", "2T8Q726O95"], "rxcui": ["602393"], "spl_set_id": ["1d8e7bb9-8624-4739-9719-fe25109d6365"], "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": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Abacavir and Lamivudine", "product_id": "68180-288_61b0304c-2258-40ed-9fc8-bc363b0906f6", "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": "68180-288", "generic_name": "Abacavir and Lamivudine", "labeler_name": "Lupin Pharmaceuticals, Inc.", "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": "ANDA204990", "marketing_category": "ANDA", "marketing_start_date": "20170328", "listing_expiration_date": "20261231"}