lamivudine

Generic: lamivudine oral

Labeler: chartwell rx, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lamivudine
Generic Name lamivudine oral
Labeler chartwell rx, llc
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

lamivudine 10 mg/mL

Manufacturer
Chartwell RX, LLC

Identifiers & Regulatory

Product NDC 62135-706
Product ID 62135-706_472f29d3-cf7e-0a76-e063-6294a90a9e7a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203564
Listing Expiration 2026-12-31
Marketing Start 2014-10-31

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 62135706
Hyphenated Format 62135-706

Supplemental Identifiers

RxCUI
199148
UPC
0362135706371
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 oral (source: ndc)
Application Number ANDA203564 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 2 TRAY in 1 BOX (62135-706-24) / 10 CUP in 1 TRAY / 30 mL in 1 CUP (62135-706-30)
  • 240 mL in 1 BOTTLE, PLASTIC (62135-706-37)
source: ndc

Packages (2)

62135-706-24 2 TRAY in 1 BOX (62135-706-24) / 10 CUP in 1 TRAY / 30 mL in 1 CUP (62135-706-30) 62135-706-37 240 mL in 1 BOTTLE, PLASTIC (62135-706-37)

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": "472f29d3-cf7e-0a76-e063-6294a90a9e7a", "openfda": {"nui": ["N0000175656", "N0000175462", "N0000009947"], "upc": ["0362135706371"], "unii": ["2T8Q726O95"], "rxcui": ["199148"], "spl_set_id": ["ef9977cb-ec91-46d7-b769-d26decfd6fe7"], "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": ["Chartwell RX, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TRAY in 1 BOX (62135-706-24)  / 10 CUP in 1 TRAY / 30 mL in 1 CUP (62135-706-30)", "package_ndc": "62135-706-24", "marketing_start_date": "20250306"}, {"sample": false, "description": "240 mL in 1 BOTTLE, PLASTIC (62135-706-37)", "package_ndc": "62135-706-37", "marketing_start_date": "20230720"}], "brand_name": "lamivudine", "product_id": "62135-706_472f29d3-cf7e-0a76-e063-6294a90a9e7a", "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": "62135-706", "generic_name": "lamivudine oral", "labeler_name": "Chartwell RX, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "lamivudine", "active_ingredients": [{"name": "LAMIVUDINE", "strength": "10 mg/mL"}], "application_number": "ANDA203564", "marketing_category": "ANDA", "marketing_start_date": "20141031", "listing_expiration_date": "20261231"}