lamivudine and zidovudine (65862-036)

Drug Facts

Product Profile

Brand Name lamivudine and zidovudine

Generic Name lamivudine and zidovudine

Labeler aurobindo pharma limited

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

lamivudine 150 mg/1, zidovudine 300 mg/1

Manufacturer

Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 65862-036

Product ID 65862-036_c4e0edda-dad5-4bed-b108-b6aae30e3be3

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA077558

Listing Expiration 2026-12-31

Marketing Start 2017-05-05

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 65862036

Hyphenated Format 65862-036

Supplemental Identifiers

RxCUI

200082

UNII

2T8Q726O95 4B9XT59T7S

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 and zidovudine (source: ndc)

Generic Name lamivudine and zidovudine (source: ndc)

Application Number ANDA077558 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

150 mg/1
300 mg/1

source: ndc

Packaging

6 BLISTER PACK in 1 CARTON (65862-036-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
60 TABLET, FILM COATED in 1 BOTTLE (65862-036-60)

source: ndc

Packages (2)

65862-036-10 6 BLISTER PACK in 1 CARTON (65862-036-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK 65862-036-60 60 TABLET, FILM COATED in 1 BOTTLE (65862-036-60)

Ingredients (2)

lamivudine (150 mg/1) zidovudine (300 mg/1)

Linked Drug Pages (1)

Lamivudine and Zidovudine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "c4e0edda-dad5-4bed-b108-b6aae30e3be3", "openfda": {"nui": ["N0000175656", "N0000175462", "N0000009947"], "unii": ["2T8Q726O95", "4B9XT59T7S"], "rxcui": ["200082"], "spl_set_id": ["d40292ff-046c-4a04-b801-10768667951a"], "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": "6 BLISTER PACK in 1 CARTON (65862-036-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "65862-036-10", "marketing_start_date": "20170505"}, {"sample": false, "description": "60 TABLET, FILM COATED in 1 BOTTLE (65862-036-60)", "package_ndc": "65862-036-60", "marketing_start_date": "20170505"}], "brand_name": "Lamivudine and Zidovudine", "product_id": "65862-036_c4e0edda-dad5-4bed-b108-b6aae30e3be3", "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]", "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]", "Nucleoside Reverse Transcriptase Inhibitors [MoA]"], "product_ndc": "65862-036", "generic_name": "Lamivudine and Zidovudine", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lamivudine and Zidovudine", "active_ingredients": [{"name": "LAMIVUDINE", "strength": "150 mg/1"}, {"name": "ZIDOVUDINE", "strength": "300 mg/1"}], "application_number": "ANDA077558", "marketing_category": "ANDA", "marketing_start_date": "20170505", "listing_expiration_date": "20261231"}