68071-1916 NDC - LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE ()

Drug Information

Product NDC: 68071-1916
Proprietary Name: Losartan Potassium and Hydrochlorothiazide
Non Proprietary Name:
Active Ingredient(s):
Administration Route(s):
Dosage Form(s):

Labeler Information

Field Name	Field Value
Labeler Name:	NuCare Pharmaceuticals, Inc.
Product Type:
FDA Application Number:	ANDA091629
Marketing Category:	ANDA
Start Marketing Date:	10/6/2010
End Marketing Date:	12/31/2021

Package Information

No.	Package Code	Package Description	Billing Unit
1	68071-1916-3	30 TABLET, FILM COATED in 1 BOTTLE (68071-1916-3)
2	68071-1916-9	90 TABLET, FILM COATED in 1 BOTTLE (68071-1916-9)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	68071-1916	The 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.
PROPRIETARY NAME	Losartan Potassium and Hydrochlorothiazide	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE	10/6/2010	The 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.
END MARKETING DATE	12/31/2021	Indicates 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.
MARKETING CATEGORY NAME	ANDA	Product 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 NUMBER	ANDA091629	The translation of the dosage form Code submitted by the firm.
LABELER NAME	NuCare Pharmaceuticals, Inc.	Name of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 12/6/2025

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