triamterene and hydrochlorothiazide

Generic: triamterene and hydrochlorothiazide

Labeler: zydus pharmaceuticals (usa) inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name triamterene and hydrochlorothiazide
Generic Name triamterene and hydrochlorothiazide
Labeler zydus pharmaceuticals (usa) inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrochlorothiazide 50 mg/1, triamterene 75 mg/1

Manufacturer
Zydus Pharmaceuticals (USA) Inc.

Identifiers & Regulatory

Product NDC 68382-857
Product ID 68382-857_e0a51d55-991a-463a-a382-428f33488d77
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208360
Listing Expiration 2026-12-31
Marketing Start 2018-09-04

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 68382857
Hyphenated Format 68382-857

Supplemental Identifiers

RxCUI
310812 310818
UPC
0368382856012 0368382857019
UNII
0J48LPH2TH WS821Z52LQ
NUI
N0000175359 N0000175419 M0471776 N0000008859 N0000175418

Packaging Origin

Original Packager
true

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 ANDA208360 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (68382-857-01)
  • 500 TABLET in 1 BOTTLE (68382-857-05)
  • 1000 TABLET in 1 BOTTLE (68382-857-10)
  • 10 BLISTER PACK in 1 CARTON (68382-857-77) / 10 TABLET in 1 BLISTER PACK (68382-857-30)
source: ndc

Packages (4)

68382-857-01 100 TABLET in 1 BOTTLE (68382-857-01) 68382-857-05 500 TABLET in 1 BOTTLE (68382-857-05) 68382-857-10 1000 TABLET in 1 BOTTLE (68382-857-10) 68382-857-77 10 BLISTER PACK in 1 CARTON (68382-857-77) / 10 TABLET in 1 BLISTER PACK (68382-857-30)

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": "e0a51d55-991a-463a-a382-428f33488d77", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000008859", "N0000175418"], "upc": ["0368382856012", "0368382857019"], "unii": ["0J48LPH2TH", "WS821Z52LQ"], "rxcui": ["310812", "310818"], "spl_set_id": ["fa69eeb8-ec82-4be1-8cb7-f64094ed957c"], "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": ["Zydus Pharmaceuticals (USA) Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE (68382-857-01)", "package_ndc": "68382-857-01", "marketing_start_date": "20180904"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (68382-857-05)", "package_ndc": "68382-857-05", "marketing_start_date": "20180904"}, {"sample": false, "description": "1000 TABLET in 1 BOTTLE (68382-857-10)", "package_ndc": "68382-857-10", "marketing_start_date": "20180904"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-857-77)  / 10 TABLET in 1 BLISTER PACK (68382-857-30)", "package_ndc": "68382-857-77", "marketing_start_date": "20180904"}], "brand_name": "triamterene and hydrochlorothiazide", "product_id": "68382-857_e0a51d55-991a-463a-a382-428f33488d77", "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": "68382-857", "generic_name": "triamterene and hydrochlorothiazide", "labeler_name": "Zydus Pharmaceuticals (USA) 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": "ANDA208360", "marketing_category": "ANDA", "marketing_start_date": "20180904", "listing_expiration_date": "20261231"}