triamterene and hydrochlorothiazide
Generic: triamterene and hydrochlorothiazide
Labeler: zydus pharmaceuticals (usa) inc.Drug Facts
Product Profile
Brand Name
triamterene and hydrochlorothiazide
Generic Name
triamterene and hydrochlorothiazide
Labeler
zydus pharmaceuticals (usa) inc.
Dosage Form
CAPSULE
Routes
Active Ingredients
hydrochlorothiazide 25 mg/1, triamterene 37.5 mg/1
Manufacturer
Identifiers & Regulatory
Product NDC
68382-855
Product ID
68382-855_062dc3f3-09ea-4f21-9435-025c4e9d460b
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA208358
Listing Expiration
2026-12-31
Marketing Start
2019-03-31
Pharmacologic Class
Established (EPC)
Chemical Structure
Physiologic Effect
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
68382855
Hyphenated Format
68382-855
Supplemental Identifiers
RxCUI
UNII
NUI
Packaging Origin
Original Packager
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
ANDA208358 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 25 mg/1
- 37.5 mg/1
Packaging
- 100 CAPSULE in 1 BOTTLE (68382-855-01)
- 500 CAPSULE in 1 BOTTLE (68382-855-05)
- 1000 CAPSULE in 1 BOTTLE (68382-855-10)
- 10 BLISTER PACK in 1 CARTON (68382-855-77) / 10 CAPSULE in 1 BLISTER PACK (68382-855-30)
Packages (4)
Ingredients (2)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "062dc3f3-09ea-4f21-9435-025c4e9d460b", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776", "N0000008859", "N0000175418"], "unii": ["0J48LPH2TH", "WS821Z52LQ"], "rxcui": ["198316"], "spl_set_id": ["ee11db7b-91bd-4231-8783-889d98e4fa32"], "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 CAPSULE in 1 BOTTLE (68382-855-01)", "package_ndc": "68382-855-01", "marketing_start_date": "20190331"}, {"sample": false, "description": "500 CAPSULE in 1 BOTTLE (68382-855-05)", "package_ndc": "68382-855-05", "marketing_start_date": "20190331"}, {"sample": false, "description": "1000 CAPSULE in 1 BOTTLE (68382-855-10)", "package_ndc": "68382-855-10", "marketing_start_date": "20190331"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (68382-855-77) / 10 CAPSULE in 1 BLISTER PACK (68382-855-30)", "package_ndc": "68382-855-77", "marketing_start_date": "20190331"}], "brand_name": "Triamterene and Hydrochlorothiazide", "product_id": "68382-855_062dc3f3-09ea-4f21-9435-025c4e9d460b", "dosage_form": "CAPSULE", "pharm_class": ["Decreased Renal K+ Excretion [PE]", "Increased Diuresis [PE]", "Increased Diuresis [PE]", "Potassium-sparing Diuretic [EPC]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "68382-855", "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": "25 mg/1"}, {"name": "TRIAMTERENE", "strength": "37.5 mg/1"}], "application_number": "ANDA208358", "marketing_category": "ANDA", "marketing_start_date": "20190331", "listing_expiration_date": "20261231"}