triamterene and hydrochlorothiazide

Generic: triamterene and hydrochlorothiazide

Labeler: advagen pharma ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name triamterene and hydrochlorothiazide
Generic Name triamterene and hydrochlorothiazide
Labeler advagen pharma ltd
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrochlorothiazide 50 mg/1, triamterene 75 mg/1

Manufacturer
Advagen Pharma Ltd

Identifiers & Regulatory

Product NDC 72888-095
Product ID 72888-095_47ca5405-6d4e-755a-e063-6394a90acbfc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216211
Listing Expiration 2027-12-31
Marketing Start 2022-02-23

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 72888095
Hyphenated Format 72888-095

Supplemental Identifiers

RxCUI
310812 310818
UPC
0372888094014 0372888094007 0372888095301 0372888094052 0372888095011 0372888094304 0372888095059 0372888095004
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 ANDA216211 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/1
  • 75 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (72888-095-00)
  • 100 TABLET in 1 BOTTLE (72888-095-01)
  • 500 TABLET in 1 BOTTLE (72888-095-05)
  • 30 TABLET in 1 BOTTLE (72888-095-30)
source: ndc

Packages (4)

Ingredients (2)

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

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "47ca5405-6d4e-755a-e063-6394a90acbfc", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000008859", "N0000175418"], "upc": ["0372888094014", "0372888094007", "0372888095301", "0372888094052", "0372888095011", "0372888094304", "0372888095059", "0372888095004"], "unii": ["0J48LPH2TH", "WS821Z52LQ"], "rxcui": ["310812", "310818"], "spl_set_id": ["a5525a2a-d2c7-411b-9ffc-0cc4fe77f7c7"], "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": ["Advagen Pharma Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (72888-095-00)", "package_ndc": "72888-095-00", "marketing_start_date": "20230202"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (72888-095-01)", "package_ndc": "72888-095-01", "marketing_start_date": "20230202"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (72888-095-05)", "package_ndc": "72888-095-05", "marketing_start_date": "20230202"}, {"sample": false, "description": "30 TABLET in 1 BOTTLE (72888-095-30)", "package_ndc": "72888-095-30", "marketing_start_date": "20230202"}], "brand_name": "Triamterene and Hydrochlorothiazide", "product_id": "72888-095_47ca5405-6d4e-755a-e063-6394a90acbfc", "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": "72888-095", "generic_name": "Triamterene and Hydrochlorothiazide", "labeler_name": "Advagen Pharma Ltd", "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": "20220223", "listing_expiration_date": "20271231"}