lamivudine

Generic: lamivudine

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamivudine
Generic Name lamivudine
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lamivudine 300 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-026
Product ID 65862-026_0c6a0ca4-d63c-4018-909a-d9e7a2821ed4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077464
Listing Expiration 2026-12-31
Marketing Start 2016-11-21

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 65862026
Hyphenated Format 65862-026

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 ANDA077464 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (65862-026-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 30 TABLET, FILM COATED in 1 BOTTLE (65862-026-30)
source: ndc

Packages (2)

65862-026-10 3 BLISTER PACK in 1 CARTON (65862-026-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 65862-026-30 30 TABLET, FILM COATED in 1 BOTTLE (65862-026-30)

Ingredients (1)

lamivudine (300 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": "0c6a0ca4-d63c-4018-909a-d9e7a2821ed4", "openfda": {"nui": ["N0000175656", "N0000175462", "N0000009947"], "unii": ["2T8Q726O95"], "rxcui": ["199147", "349491"], "spl_set_id": ["a8a492ab-396a-4b7c-99b3-bcb6d3386f71"], "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": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (65862-026-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-026-10", "marketing_start_date": "20161121"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (65862-026-30)", "package_ndc": "65862-026-30", "marketing_start_date": "20161121"}], "brand_name": "Lamivudine", "product_id": "65862-026_0c6a0ca4-d63c-4018-909a-d9e7a2821ed4", "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": "65862-026", "generic_name": "Lamivudine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamivudine", "active_ingredients": [{"name": "LAMIVUDINE", "strength": "300 mg/1"}], "application_number": "ANDA077464", "marketing_category": "ANDA", "marketing_start_date": "20161121", "listing_expiration_date": "20261231"}