lamivudine

Generic: lamivudine

Labeler: coupler llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamivudine
Generic Name lamivudine
Labeler coupler llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lamivudine 150 mg/1

Manufacturer
Coupler LLC

Identifiers & Regulatory

Product NDC 67046-1459
Product ID 67046-1459_2d7daacc-a9ed-2f30-e063-6294a90a4a57
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA090457
Listing Expiration 2026-12-31
Marketing Start 2025-02-06

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 670461459
Hyphenated Format 67046-1459

Supplemental Identifiers

RxCUI
199147
UNII
2T8Q726O95
NUI
N0000175656 N0000175462 N0000009947

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 ANDA090457 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1459-3)
source: ndc

Packages (1)

67046-1459-3 30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1459-3)

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": "2d7daacc-a9ed-2f30-e063-6294a90a4a57", "openfda": {"nui": ["N0000175656", "N0000175462", "N0000009947"], "unii": ["2T8Q726O95"], "rxcui": ["199147"], "spl_set_id": ["2d7db3b2-9b3c-3031-e063-6294a90a342c"], "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": ["Coupler LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BLISTER PACK (67046-1459-3)", "package_ndc": "67046-1459-3", "marketing_start_date": "20250206"}], "brand_name": "Lamivudine", "product_id": "67046-1459_2d7daacc-a9ed-2f30-e063-6294a90a4a57", "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": "67046-1459", "generic_name": "Lamivudine", "labeler_name": "Coupler LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamivudine", "active_ingredients": [{"name": "LAMIVUDINE", "strength": "150 mg/1"}], "application_number": "ANDA090457", "marketing_category": "ANDA", "marketing_start_date": "20250206", "listing_expiration_date": "20261231"}