Home NDC 0781-2715-01 Triamterene and Hydrochlorothiazide
Product NDC 0781-2715
Requested package NDC 0781-2715-01
11-digit product format 007812715
Labeler code 0781
Product ID 0781-2715_ea03a6fb-76da-42f0-a855-81c50bec2240
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Triamterene and Hydrochlorothiazide
Dosage form CAPSULE
Route ORAL
Labeler Sandoz Inc
Application ANDA073191
Marketing category ANDA
Marketing start 1991-07-31
Marketing end 2021-08-31
Substance TRIAMTERENE; HYDROCHLOROTHIAZIDE
Active strength 50 mg/1; mg/1
Pharmacologic classes Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC],Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE; TRIAMTERENE 25MG;50MG CAPSULE / ORAL 1991-07-31
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 a50c72e98297…
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 TRIAMTERENE ACTIVE INGREDIENT WS821Z52LQ TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 TRIAMTERENE ACTIVE MOIETY WS821Z52LQ TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 DIMETHICONE INACTIVE INGREDIENT 92RU3N3Y1O TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 FD&C BLUE NO. 1 INACTIVE INGREDIENT H3R47K3TBD TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 GELATIN INACTIVE INGREDIENT 2G86QN327L TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 GLYCINE INACTIVE INGREDIENT TE7660XO1C TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 POVIDONE INACTIVE INGREDIENT FZ989GH94E TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 SHELLAC INACTIVE INGREDIENT 46N107B71O TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0781-2715 TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [SANDOZ INC] 22 Legacy NDC 20240724_f824b6ba-bd1c-41a8-8f6f-ad507b48f3e0.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0781-2715-01 00781271501 100 CAPSULE in 1 BOTTLE (0781-2715-01) 100 capsule 1991-07-31 2021-08-31 No No Current