68382-855 NDC - TRIAMTERENE AND HYDROCHLOROTHIAZIDE

Drug Information

  • Product NDC: 68382-855
  • Proprietary Name: Triamterene and Hydrochlorothiazide
  • Non Proprietary Name: Triamterene and Hydrochlorothiazide
  • Active Ingredient(s): 25 mg/1 HYDROCHLOROTHIAZIDE; 37.5 mg/1 TRIAMTERENE
  • Administration Route(s): ORAL
  • Dosage Form(s): CAPSULE
  • Pharmacy Class(es): Decreased Renal K+ Excretion [PE]; Increased Diuresis [PE]; Increased Diuresis [PE]; Potassium-sparing Diuretic [EPC]; Thiazide Diuretic [EPC]; Thiazides [CS]

Labeler Information

Field Name Field Value
Labeler Name: Zydus Pharmaceuticals (USA) Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA208358
Marketing Category: ANDA
Start Marketing Date:3/31/2019

Package Information

No. Package Code Package Description Billing Unit
168382-855-01100 CAPSULE in 1 BOTTLE (68382-855-01)
268382-855-05500 CAPSULE in 1 BOTTLE (68382-855-05)
368382-855-101000 CAPSULE in 1 BOTTLE (68382-855-10)
468382-855-7710 BLISTER PACK in 1 CARTON (68382-855-77) / 10 CAPSULE in 1 BLISTER PACK (68382-855-30)

NDC Record

Field Name Field Value Definition
PRODUCT NDC68382-855This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGName of Company corresponding to the labeler code segment of the Product NDC.
PROPRIETARY NAMETriamterene and HydrochlorothiazideName of Company corresponding to the labeler code segment of the Product NDC.
NON PROPRIETARY NAMETriamterene and HydrochlorothiazideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMECAPSULEThe 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 DATE3/31/2019This 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 NUMBERANDA208358The 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.
LABELER NAMEZydus Pharmaceuticals (USA) Inc.Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEHYDROCHLOROTHIAZIDE; TRIAMTERENEAn 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 STRENGTH25; 37.5 
ACTIVE INGRED UNITmg/1; mg/1 
PHARM CLASSESDecreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS] 

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This page was last updated on: 1/16/2026

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