lamivudine and zidovudine (33342-003)

Drug Facts

Product Profile

Brand Name lamivudine and zidovudine

Generic Name lamivudine and zidovudine

Labeler macleods pharmaceuticals limited

Dosage Form TABLET

Routes

ORAL

Active Ingredients

lamivudine 150 mg/1, zidovudine 300 mg/1

Manufacturer

Macleods Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 33342-003

Product ID 33342-003_c28a7cc4-0638-4fc2-a549-a87887e8d50e

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA090679

Listing Expiration 2026-12-31

Marketing Start 2018-08-30

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 33342003

Hyphenated Format 33342-003

Supplemental Identifiers

RxCUI

200082

UPC

0333342003096

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 ANDA090679 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

150 mg/1
300 mg/1

source: ndc

Packaging

60 TABLET in 1 BOTTLE (33342-003-09)

source: ndc

Packages (1)

33342-003-09 60 TABLET in 1 BOTTLE (33342-003-09)

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": "c28a7cc4-0638-4fc2-a549-a87887e8d50e", "openfda": {"nui": ["N0000175656", "N0000175462", "N0000009947"], "upc": ["0333342003096"], "unii": ["2T8Q726O95", "4B9XT59T7S"], "rxcui": ["200082"], "spl_set_id": ["63667952-be01-483e-9887-1d5417e7ec16"], "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": ["Macleods Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET in 1 BOTTLE (33342-003-09)", "package_ndc": "33342-003-09", "marketing_start_date": "20180830"}], "brand_name": "Lamivudine and Zidovudine", "product_id": "33342-003_c28a7cc4-0638-4fc2-a549-a87887e8d50e", "dosage_form": "TABLET", "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 Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "33342-003", "generic_name": "Lamivudine and Zidovudine", "labeler_name": "Macleods Pharmaceuticals Limited", "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": "ANDA090679", "marketing_category": "ANDA", "marketing_start_date": "20180830", "listing_expiration_date": "20261231"}