lamivudine and zidovudine (76282-115)

Drug Facts

Product Profile

Brand Name lamivudine and zidovudine

Generic Name lamivudine and zidovudine

Labeler exelan pharmaceuticals inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

lamivudine 150 mg/1, zidovudine 300 mg/1

Manufacturer

Exelan Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 76282-115

Product ID 76282-115_9d9239ba-eadd-45f3-a528-f9e2f7e2db04

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA203259

Listing Expiration 2026-12-31

Marketing Start 2015-04-29

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 76282115

Hyphenated Format 76282-115

Supplemental Identifiers

RxCUI

200082

UPC

0376282115603

UNII

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 lamivudine and zidovudine (source: ndc)

Generic Name lamivudine and zidovudine (source: ndc)

Application Number ANDA203259 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

150 mg/1
300 mg/1

source: ndc

Packaging

500 TABLET, FILM COATED in 1 BOTTLE (76282-115-05)
60 TABLET, FILM COATED in 1 BOTTLE (76282-115-60)

source: ndc

Packages (2)

76282-115-05 500 TABLET, FILM COATED in 1 BOTTLE (76282-115-05) 76282-115-60 60 TABLET, FILM COATED in 1 BOTTLE (76282-115-60)

Ingredients (2)

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

Linked Drug Pages (1)

Lamivudine and Zidovudine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "9d9239ba-eadd-45f3-a528-f9e2f7e2db04", "openfda": {"nui": ["N0000175656", "N0000175462", "N0000009947"], "upc": ["0376282115603"], "unii": ["2T8Q726O95", "4B9XT59T7S"], "rxcui": ["200082"], "spl_set_id": ["4cf565c3-bdec-4c18-93c1-cc7fa8331c90"], "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": ["Exelan Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (76282-115-05)", "package_ndc": "76282-115-05", "marketing_start_date": "20150429"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (76282-115-60)", "package_ndc": "76282-115-60", "marketing_start_date": "20150429"}], "brand_name": "Lamivudine and Zidovudine", "product_id": "76282-115_9d9239ba-eadd-45f3-a528-f9e2f7e2db04", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["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 Analog [EXT]", "Nucleoside Analog [EXT]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "76282-115", "generic_name": "Lamivudine and Zidovudine", "labeler_name": "Exelan Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamivudine and Zidovudine", "active_ingredients": [{"name": "LAMIVUDINE", "strength": "150 mg/1"}, {"name": "ZIDOVUDINE", "strength": "300 mg/1"}], "application_number": "ANDA203259", "marketing_category": "ANDA", "marketing_start_date": "20150429", "listing_expiration_date": "20261231"}