71335-0141 NDC - LAMIVUDINE AND ZIDOVUDINE

Drug Information

  • Product NDC: 71335-0141
  • Proprietary Name: Lamivudine and Zidovudine
  • Non Proprietary Name: Lamivudine and Zidovudine
  • Active Ingredient(s): 150 mg/1 LAMIVUDINE; 300 mg/1 ZIDOVUDINE
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET
  • Pharmacy Class(es): 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]

Labeler Information

Field Name Field Value
Labeler Name: Bryant Ranch Prepack
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA079128
Marketing Category: ANDA
Start Marketing Date:12/10/2016

Package Information

No. Package Code Package Description Billing Unit
171335-0141-16 TABLET in 1 BOTTLE (71335-0141-1)
271335-0141-260 TABLET in 1 BOTTLE (71335-0141-2)
371335-0141-34 TABLET in 1 BOTTLE (71335-0141-3)

NDC Record

Field Name Field Value Definition
PRODUCT NDC71335-0141The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
PROPRIETARY NAMELamivudine and ZidovudineThe translation of the dosage form Code submitted by the firm.
NON PROPRIETARY NAMELamivudine and ZidovudineThe translation of the route code submitted by the firm, indicating route of administration.
DOSAGE FORM NAMETABLETThis is the date that the labeler indicates was the start of its marketing of the drug product.
ROUTE NAMEORALProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
START MARKETING DATE12/10/2016This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEANDAProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERANDA079128This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEBryant Ranch PrepackName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMELAMIVUDINE; ZIDOVUDINEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH150; 300 
ACTIVE INGRED UNITmg/1; mg/1 
PHARM CLASSESHepatitis 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] 

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This page was last updated on: 12/19/2025

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