lamivudine

Generic: lamivudine

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamivudine
Generic Name lamivudine
Labeler apotex corp.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lamivudine 150 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-3251
Product ID 60505-3251_2cca5476-aba6-0525-0bb5-890f2ca25bb7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091606
Listing Expiration 2026-12-31
Marketing Start 2011-12-02

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 605053251
Hyphenated Format 60505-3251

Supplemental Identifiers

RxCUI
199147 349491
UNII
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 lamivudine (source: ndc)
Generic Name lamivudine (source: ndc)
Application Number ANDA091606 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 60 TABLET, FILM COATED in 1 BOTTLE (60505-3251-6)
  • 1000 TABLET, FILM COATED in 1 BOTTLE (60505-3251-8)
source: ndc

Packages (2)

60505-3251-6 60 TABLET, FILM COATED in 1 BOTTLE (60505-3251-6) 60505-3251-8 1000 TABLET, FILM COATED in 1 BOTTLE (60505-3251-8)

Ingredients (1)

lamivudine (150 mg/1)

Linked Drug Pages (1)

LAMIVUDINE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2cca5476-aba6-0525-0bb5-890f2ca25bb7", "openfda": {"nui": ["N0000175656", "N0000175462", "N0000009947"], "unii": ["2T8Q726O95"], "rxcui": ["199147", "349491"], "spl_set_id": ["34c02bcc-d6ff-99d4-8e6a-4a91908adca8"], "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": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (60505-3251-6)", "package_ndc": "60505-3251-6", "marketing_start_date": "20111202"}, {"sample": false, "description": "1000 TABLET, FILM COATED in 1 BOTTLE (60505-3251-8)", "package_ndc": "60505-3251-8", "marketing_start_date": "20111202"}], "brand_name": "LAMIVUDINE", "product_id": "60505-3251_2cca5476-aba6-0525-0bb5-890f2ca25bb7", "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]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "60505-3251", "generic_name": "lamivudine", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "LAMIVUDINE", "active_ingredients": [{"name": "LAMIVUDINE", "strength": "150 mg/1"}], "application_number": "ANDA091606", "marketing_category": "ANDA", "marketing_start_date": "20111202", "listing_expiration_date": "20261231"}