triamterene and hydrochlorothiazide

Generic: triamterene and hydrochlorothiazide

Labeler: preferred pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name triamterene and hydrochlorothiazide
Generic Name triamterene and hydrochlorothiazide
Labeler preferred pharmaceuticals inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrochlorothiazide 50 mg/1, triamterene 75 mg/1

Manufacturer
Preferred Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 68788-8624
Product ID 68788-8624_b7589c66-17d0-4b44-a504-d30fbc734808
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216211
Listing Expiration 2026-12-31
Marketing Start 2024-04-08

Pharmacologic Class

Established (EPC)
thiazide diuretic [epc] potassium-sparing diuretic [epc]
Chemical Structure
thiazides [cs]
Physiologic Effect
increased diuresis [pe] decreased renal k+ excretion [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 687888624
Hyphenated Format 68788-8624

Supplemental Identifiers

RxCUI
310818
UNII
0J48LPH2TH WS821Z52LQ
NUI
N0000175359 N0000175419 M0471776 N0000008859 N0000175418

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name triamterene and hydrochlorothiazide (source: ndc)
Generic Name triamterene and hydrochlorothiazide (source: ndc)
Application Number ANDA216211 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68788-8624-1)
  • 30 TABLET in 1 BOTTLE (68788-8624-3)
  • 60 TABLET in 1 BOTTLE (68788-8624-6)
  • 90 TABLET in 1 BOTTLE (68788-8624-9)
source: ndc

Packages (4)

68788-8624-1 100 TABLET in 1 BOTTLE (68788-8624-1) 68788-8624-3 30 TABLET in 1 BOTTLE (68788-8624-3) 68788-8624-6 60 TABLET in 1 BOTTLE (68788-8624-6) 68788-8624-9 90 TABLET in 1 BOTTLE (68788-8624-9)

Ingredients (2)

hydrochlorothiazide (50 mg/1) triamterene (75 mg/1)

Linked Drug Pages (1)

Triamterene and Hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "b7589c66-17d0-4b44-a504-d30fbc734808", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000008859", "N0000175418"], "unii": ["0J48LPH2TH", "WS821Z52LQ"], "rxcui": ["310818"], "spl_set_id": ["5fc69fbf-c2d2-41ef-99bb-62a76ef74db2"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]", "Decreased Renal K+ Excretion [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]", "Potassium-sparing Diuretic [EPC]"], "manufacturer_name": ["Preferred Pharmaceuticals Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68788-8624-1)", "package_ndc": "68788-8624-1", "marketing_start_date": "20240408"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (68788-8624-3)", "package_ndc": "68788-8624-3", "marketing_start_date": "20240408"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (68788-8624-6)", "package_ndc": "68788-8624-6", "marketing_start_date": "20240408"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68788-8624-9)", "package_ndc": "68788-8624-9", "marketing_start_date": "20240408"}], "brand_name": "Triamterene and Hydrochlorothiazide", "product_id": "68788-8624_b7589c66-17d0-4b44-a504-d30fbc734808", "dosage_form": "TABLET", "pharm_class": ["Decreased Renal K+ Excretion [PE]", "Increased Diuresis [PE]", "Increased Diuresis [PE]", "Potassium-sparing Diuretic [EPC]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "68788-8624", "generic_name": "Triamterene and Hydrochlorothiazide", "labeler_name": "Preferred Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Triamterene and Hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "50 mg/1"}, {"name": "TRIAMTERENE", "strength": "75 mg/1"}], "application_number": "ANDA216211", "marketing_category": "ANDA", "marketing_start_date": "20240408", "listing_expiration_date": "20261231"}