68180-286 NDC - ABACAVIR, LAMIVUDINE AND ZIDOVUDINE (ABACAVIR , LAMIVUDINE AND ZIDOVUDINE)

Drug Information

Product NDC: 68180-286

Proprietary Name: ABACAVIR, LAMIVUDINE AND ZIDOVUDINE

Non Proprietary Name: ABACAVIR , LAMIVUDINE AND ZIDOVUDINE

Active Ingredient(s):
  • 300 mg/1 ABACAVIR SULFATE;
  • 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];
  • Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC];
  • Nucleoside Analog [EXT];
  • Nucleoside Analog [EXT];
  • Nucleoside Analog [EXT];
  • Nucleoside Reverse Transcriptase Inhibitors [MoA];
  • Nucleoside Reverse Transcriptase Inhibitors [MoA];
  • Nucleoside Reverse Transcriptase Inhibitors [MoA]

Labeler Information

Labeler Name: Lupin Pharmaceuticals, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA202912
Marketing Category: ANDA
Start Marketing Date:12/17/2013

Package Information

No. Package Code Package Description Billing Unit
168180-286-011 BOTTLE in 1 CARTON (68180-286-01) / 100 TABLET in 1 BOTTLE
268180-286-021 BOTTLE in 1 CARTON (68180-286-02) / 500 TABLET in 1 BOTTLE
368180-286-071 BOTTLE in 1 CARTON (68180-286-07) / 60 TABLET in 1 BOTTLEEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC68180-286The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEABACAVIR, LAMIVUDINE AND ZIDOVUDINEThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEABACAVIR , LAMIVUDINE AND ZIDOVUDINEThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLETThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE12/17/2013This 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 NUMBERANDA202912This 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 NAMELupin Pharmaceuticals, Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEABACAVIR SULFATE; LAMIVUDINE; 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 STRENGTH300; 150; 300 
ACTIVE INGRED UNITmg/1; mg/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], Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC], Nucleoside Analog [EXT], Nucleoside Analog [EXT], Nucleoside Analog [EXT], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA], Nucleoside Reverse Transcriptase Inhibitors [MoA] 

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This page was last updated on: 2/1/2023