triamterene and hydrochlorothiazide

Generic: triamterene and hydrochlorothiazide

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name triamterene and hydrochlorothiazide
Generic Name triamterene and hydrochlorothiazide
Labeler zydus lifesciences limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

hydrochlorothiazide 25 mg/1, triamterene 37.5 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1361
Product ID 70771-1361_1b1be913-613c-469c-8665-13858922d5bf
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 707711361
Hyphenated Format 70771-1361

Supplemental Identifiers

RxCUI
310812 310818
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
  • 25 mg/1
  • 37.5 mg/1
source: ndc
Packaging
  • 1000 TABLET in 1 BOTTLE (70771-1361-0)
  • 100 TABLET in 1 BOTTLE (70771-1361-1)
  • 10 BLISTER PACK in 1 CARTON (70771-1361-4) / 10 TABLET in 1 BLISTER PACK
  • 500 TABLET in 1 BOTTLE (70771-1361-5)
source: ndc

Packages (4)

70771-1361-0 1000 TABLET in 1 BOTTLE (70771-1361-0) 70771-1361-1 100 TABLET in 1 BOTTLE (70771-1361-1) 70771-1361-4 10 BLISTER PACK in 1 CARTON (70771-1361-4) / 10 TABLET in 1 BLISTER PACK 70771-1361-5 500 TABLET in 1 BOTTLE (70771-1361-5)

Ingredients (2)

hydrochlorothiazide (25 mg/1) triamterene (37.5 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": "1b1be913-613c-469c-8665-13858922d5bf", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000008859", "N0000175418"], "unii": ["0J48LPH2TH", "WS821Z52LQ"], "rxcui": ["310812", "310818"], "spl_set_id": ["1af80800-e7a5-42e5-aa6c-3f61aff4a77b"], "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 Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 TABLET in 1 BOTTLE (70771-1361-0)", "package_ndc": "70771-1361-0", "marketing_start_date": "20180904"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (70771-1361-1)", "package_ndc": "70771-1361-1", "marketing_start_date": "20180904"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (70771-1361-4)  / 10 TABLET in 1 BLISTER PACK", "package_ndc": "70771-1361-4", "marketing_start_date": "20180904"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE (70771-1361-5)", "package_ndc": "70771-1361-5", "marketing_start_date": "20180904"}], "brand_name": "triamterene and hydrochlorothiazide", "product_id": "70771-1361_1b1be913-613c-469c-8665-13858922d5bf", "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": "70771-1361", "generic_name": "triamterene and hydrochlorothiazide", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "triamterene and hydrochlorothiazide", "active_ingredients": [{"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "TRIAMTERENE", "strength": "37.5 mg/1"}], "application_number": "ANDA208360", "marketing_category": "ANDA", "marketing_start_date": "20180904", "listing_expiration_date": "20261231"}