abacavir, lamivudine and zidovudine (68180-286)

Drug Facts

Product Profile

Brand Name abacavir, lamivudine and zidovudine

Generic Name abacavir , lamivudine and zidovudine

Labeler lupin pharmaceuticals, inc.

Dosage Form TABLET

Routes

ORAL

Active Ingredients

abacavir sulfate 300 mg/1, lamivudine 150 mg/1, zidovudine 300 mg/1

Manufacturer

Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-286

Product ID 68180-286_e180b9ff-1e7c-422a-9fe7-afd39eee3e4e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA202912

Listing Expiration 2026-12-31

Marketing Start 2013-12-17

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 68180286

Hyphenated Format 68180-286

Supplemental Identifiers

RxCUI

307650

UNII

J220T4J9Q2 2T8Q726O95 4B9XT59T7S

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, lamivudine and zidovudine (source: ndc)

Generic Name abacavir , lamivudine and zidovudine (source: ndc)

Application Number ANDA202912 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

300 mg/1
150 mg/1

source: ndc

Packaging

16 HOW SUPPLIED/STORAGE AND HANDLING Abacavir, lamivudine and zidovudine is available as tablets. Each tablet contains 300 mg of abacavir as abacavir sulfate, 150 mg of lamivudine, and 300 mg of zidovudine. The tablets are blue-green colored, oval shaped, biconvex, film-coated, debossed with "LU" on one side and "N51" on the other side. They are packaged as follows: Bottles of 60 Tablets NDC 68180-286-07 Bottles of 100 Tablets NDC 68180-286-01 Bottles of 500 Tablets NDC 68180-286-02 Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
ABACAVIR, LAMIVUDINE AND ZIDOVUDINE TABLETS 300 mg 150 mg 300 mg Rx only NDC 68180-286-07 Notice to Authorized Dispenser: Dispense drug product with Medication Guide and Warning Card from the carton. Each tablet contains abacavir sulfate USP equivalent to 300 mg of abacavir, 150 mg of lamivudine USP, and 300 mg of zidovudine USP. Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. See prescribing information for dosage information. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Pithampur (M.P.) - 454 775 INDIA NDC 68180-286-07 ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLETS 300 mg 150 mg 300 mg TABLETS Rx only Bottle Label: 60 Tablets NDC 68180-286-07 ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE TABLETS 300 mg 150 mg 300 mg TABLETS Rx only Carton Label: 60 Tablets

source: label

Packages (0)

No package records.

Ingredients (3)

abacavir sulfate (300 mg/1) lamivudine (150 mg/1) zidovudine (300 mg/1)

Linked Drug Pages (1)

ABACAVIR, LAMIVUDINE AND ZIDOVUDINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "e180b9ff-1e7c-422a-9fe7-afd39eee3e4e", "openfda": {"nui": ["N0000175656", "N0000175462", "N0000009947"], "unii": ["J220T4J9Q2", "2T8Q726O95", "4B9XT59T7S"], "rxcui": ["307650"], "spl_set_id": ["f5f7c0d9-a247-4308-8269-32accc490ea6"], "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, LAMIVUDINE AND ZIDOVUDINE", "product_id": "68180-286_e180b9ff-1e7c-422a-9fe7-afd39eee3e4e", "dosage_form": "TABLET", "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]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "68180-286", "generic_name": "ABACAVIR , LAMIVUDINE AND ZIDOVUDINE", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ABACAVIR, LAMIVUDINE AND ZIDOVUDINE", "active_ingredients": [{"name": "ABACAVIR SULFATE", "strength": "300 mg/1"}, {"name": "LAMIVUDINE", "strength": "150 mg/1"}, {"name": "ZIDOVUDINE", "strength": "300 mg/1"}], "application_number": "ANDA202912", "marketing_category": "ANDA", "marketing_start_date": "20131217", "listing_expiration_date": "20261231"}