Home NDC 0781-2715 Triamterene and Hydrochlorothiazide
Product NDC 0781-2715
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 48 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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.
Product history page 1 of 2 · 43 observed 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 2026-09-14 22:38:34 2026-08 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 84e616aacf4f…2026-08-18 06:07:40 2026-07 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A073191-001 TRIAMTERENE AND HYDROCHLOROTHIAZIDE 25MG;50MG CAPSULE / ORAL 1991-07-31 f41ea6bd6efb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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