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 SOLUTION
Routes
ORAL
Active Ingredients

lamivudine 10 mg/mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-055
Product ID 65862-055_c0f2da5b-9588-4740-8225-8d9d95e82c1f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077695
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 65862055
Hyphenated Format 65862-055

Supplemental Identifiers

RxCUI
199148
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 ANDA077695 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 240 mL in 1 BOTTLE (65862-055-24)
source: ndc

Packages (1)

65862-055-24 240 mL in 1 BOTTLE (65862-055-24)

Ingredients (1)

lamivudine (10 mg/mL)

Linked Drug Pages (1)

Lamivudine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "c0f2da5b-9588-4740-8225-8d9d95e82c1f", "openfda": {"nui": ["N0000175656", "N0000175462", "N0000009947"], "unii": ["2T8Q726O95"], "rxcui": ["199148"], "spl_set_id": ["ba7ee31e-e8d4-4e17-b27a-d2ce69e3bb00"], "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": "240 mL in 1 BOTTLE (65862-055-24)", "package_ndc": "65862-055-24", "marketing_start_date": "20161121"}], "brand_name": "Lamivudine", "product_id": "65862-055_c0f2da5b-9588-4740-8225-8d9d95e82c1f", "dosage_form": "SOLUTION", "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": "65862-055", "generic_name": "Lamivudine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamivudine", "active_ingredients": [{"name": "LAMIVUDINE", "strength": "10 mg/mL"}], "application_number": "ANDA077695", "marketing_category": "ANDA", "marketing_start_date": "20161121", "listing_expiration_date": "20261231"}