lamivudine and zidovudine (43063-900)

Drug Facts

Product Profile

Brand Name lamivudine and zidovudine

Generic Name lamivudine and zidovudine

Labeler pd-rx pharmaceuticals, inc.

Dosage Form TABLET, FILM COATED

Routes

ORAL

Active Ingredients

lamivudine 150 mg/1, zidovudine 300 mg/1

Manufacturer

PD-Rx Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 43063-900

Product ID 43063-900_415d1735-9f33-0e91-e063-6394a90a16de

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA079124

Listing Expiration 2026-12-31

Marketing Start 2015-09-18

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 43063900

Hyphenated Format 43063-900

Supplemental Identifiers

RxCUI

200082

UPC

0343063900062

UNII

2T8Q726O95 4B9XT59T7S

NUI

N0000175656 N0000175462 N0000009947

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 ANDA079124 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

150 mg/1
300 mg/1

source: ndc

Packaging

6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-900-06)

source: ndc

Packages (1)

43063-900-06 6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-900-06)

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": "415d1735-9f33-0e91-e063-6394a90a16de", "openfda": {"nui": ["N0000175656", "N0000175462", "N0000009947"], "upc": ["0343063900062"], "unii": ["2T8Q726O95", "4B9XT59T7S"], "rxcui": ["200082"], "spl_set_id": ["ff62c5fc-965d-4534-a571-a4f290cb9d83"], "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": ["PD-Rx Pharmaceuticals, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "6 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-900-06)", "package_ndc": "43063-900-06", "marketing_start_date": "20181011"}], "brand_name": "LAMIVUDINE and ZIDOVUDINE", "product_id": "43063-900_415d1735-9f33-0e91-e063-6394a90a16de", "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": "43063-900", "generic_name": "LAMIVUDINE and ZIDOVUDINE", "labeler_name": "PD-Rx Pharmaceuticals, Inc.", "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": "ANDA079124", "marketing_category": "ANDA", "marketing_start_date": "20150918", "listing_expiration_date": "20261231"}