Triamterene and Hydrochlorothiazide

Product NDC
51079-935
11-digit product format
510790935
Labeler code
51079
Product ID
51079-935_971908b4-60ac-17f2-e053-2995a90a20c7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
triamterene and hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA074701
Marketing category
ANDA
Marketing start
2000-04-01
Marketing end
2021-01-31
Substance
HYDROCHLOROTHIAZIDE; TRIAMTERENE
Active strength
25 mg/1; mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS],Decreased Renal K+ Excretion [PE],Increased Diuresis [PE],Potassium-sparing Diuretic [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51079-935DDiscontinued by firm2026-10-05
excluded packagepackage51079-93551079-935-20DDiscontinued by firm2026-10-05

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage51079-935-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage51079-935-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage51079-935-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage51079-935-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage51079-935-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage51079-935-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage51079-935-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage51079-935-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage51079-935-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage51079-935-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage51079-935-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage51079-935-20557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENE25MG;37.5MGCAPSULE / ORAL1996-06-07

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-0784e616aacf4f…
2026-08-18 06:07:402026-07A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1996-06-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1996-06-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1996-06-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1996-06-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1996-06-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1996-06-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1996-06-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1996-06-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1996-06-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1996-06-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1996-06-073f01610625f2…
2019-09-15 20:21 UTC2019-09A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1996-06-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1996-06-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-073a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074701-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORAL1996-06-07f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074701-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074701-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074701-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074701-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074701-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074701-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074701-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074701-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074701-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074701-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074701-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074701-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074701-001AB1ea99ee380514…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-935-01EA - Each51079-935dbabaf4f-3812-4045-a890-4b8350a7866912012-07-24
51079-935-20EA - Each51079-935beaf091e-44c9-4fc0-9827-70dfc404926412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
TRIAMTERENEACTIVE INGREDIENTWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
TRIAMTERENEACTIVE MOIETYWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
GELATININACTIVE INGREDIENT2G86QN327LTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ATRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [MYLAN INSTITUTIONAL INC.]2