69097-362 NDC - ABACAVIR AND LAMIVUDINE (ABACAVIR AND LAMIVUDINE)

Drug Information

Product NDC: 69097-362

Proprietary Name: Abacavir and Lamivudine

Non Proprietary Name: Abacavir and lamivudine

Active Ingredient(s):
  • 600 mg/1 ABACAVIR SULFATE;
  • 300 mg/1 LAMIVUDINE


Administration Route(s): ORAL

Dosage Form(s): TABLET, FILM COATED

Pharmacy Class(es):
  • Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC];
  • Nucleoside Analog [EXT];
  • Nucleoside Reverse Transcriptase Inhibitors [MoA];
  • Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC];
  • Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC];
  • Nucleoside Analog [EXT];
  • Nucleoside Reverse Transcriptase Inhibitors [MoA]

Labeler Information

Labeler Name: Cipla USA Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA091144
Marketing Category: ANDA
Start Marketing Date:3/28/2017

Package Information

No. Package Code Package Description Billing Unit
169097-362-0230 TABLET, FILM COATED in 1 BOTTLE (69097-362-02)EA

NDC Record

Field Name Field Value Definition
PRODUCT NDC69097-362The 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 and LamivudineThe 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 and lamivudineThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe 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 DATE3/28/2017This 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 NUMBERANDA091144This 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 NAMECipla USA Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEABACAVIR SULFATE; LAMIVUDINEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH600; 300 
ACTIVE INGRED UNITmg/1; mg/1 
PHARM CLASSESHuman Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA],Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [EXT],Nucleoside Reverse Transcriptase Inhibitors [MoA] 

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This page was last updated on: 9/11/2020