lamivudine

Generic: lamivudine

Labeler: lupin pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamivudine
Generic Name lamivudine
Labeler lupin pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

lamivudine 150 mg/1

Manufacturer
Lupin Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 68180-602
Product ID 68180-602_0852eda3-c1d3-426d-b73d-c7f08dfd9584
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA205217
Listing Expiration 2026-12-31
Marketing Start 2015-03-25

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 68180602
Hyphenated Format 68180-602

Supplemental Identifiers

RxCUI
199147 349491
UPC
0368180603061 0368180602071
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 ANDA205217 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 16 HOW SUPPLIED/STORAGE AND HANDLING Lamivudine Scored Tablets USP, 150 mg White to off white scored capsule shaped, film coated tablets, debossed on both tablet faces, such that, when broken in half "L" and "5" code is present on both halves of the tablet ("L" on one side and "5" on the opposite face of the tablet). Bottle of 60 tablets (NDC 68180-602-07) with child-resistant closure. Bottle of 100 tablets (NDC 68180-602-01) with child-resistant closure. Lamivudine Tablets USP, 300 mg Gray coloured capsule shaped, film coated tablets, debossed with "L" on one side and "6" on the other side. Bottle of 30 tablets (NDC 68180-603-06) with child-resistant closure. Recommended Storage: Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Lamivudine Tablets 150 mg Bottle of 60 Tablets 68180-602-07 Lamivudine Tablets 300 mg Bottle of 30 Tablets 68180-603-06 image-03 image-04
source: label

Packages (0)

No package records.

Ingredients (1)

lamivudine (150 mg/1)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "0852eda3-c1d3-426d-b73d-c7f08dfd9584", "openfda": {"nui": ["N0000175656", "N0000175462", "N0000009947"], "upc": ["0368180603061", "0368180602071"], "unii": ["2T8Q726O95"], "rxcui": ["199147", "349491"], "spl_set_id": ["ff3b5265-f533-4332-a861-d8c9c1664ffd"], "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": ["Lupin Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Lamivudine", "product_id": "68180-602_0852eda3-c1d3-426d-b73d-c7f08dfd9584", "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": "68180-602", "generic_name": "Lamivudine", "labeler_name": "Lupin Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamivudine", "active_ingredients": [{"name": "LAMIVUDINE", "strength": "150 mg/1"}], "application_number": "ANDA205217", "marketing_category": "ANDA", "marketing_start_date": "20150325", "listing_expiration_date": "20261231"}