Triamterene and Hydrochlorothiazide

Product NDC
63629-1507
11-digit product format
636291507
Labeler code
63629
Product ID
63629-1507_26d46abd-8d8e-4124-9e23-07436521752e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamterene and Hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074821
Marketing category
ANDA
Marketing start
1997-06-05
Marketing end
0000-00-00
Substance
TRIAMTERENE; HYDROCHLOROTHIAZIDE
Active strength
38 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
2023-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63629-1507DDiscontinued by firm2026-10-05
excluded packagepackage63629-150763629-1507-1DDiscontinued by firm2026-10-05
excluded packagepackage63629-150763629-1507-2DDiscontinued by firm2026-10-05
excluded packagepackage63629-150763629-1507-3DDiscontinued by firm2026-10-05
excluded packagepackage63629-150763629-1507-4DDiscontinued 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 2 · 65 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 packagepackage63629-1507-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1507-2d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1507-3d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63629-1507-4d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1507-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1507-2f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1507-3f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63629-1507-4f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1507-12ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1507-22ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1507-32ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63629-1507-42ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1507-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1507-2a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1507-3a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63629-1507-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1507-1cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1507-2cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1507-3cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63629-1507-4cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1507-1cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1507-2cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1507-3cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63629-1507-4cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1507-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1507-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1507-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63629-1507-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-1507-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-1507-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-1507-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63629-1507-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-1507-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-1507-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-1507-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63629-1507-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-1507-1ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-1507-2ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-1507-3ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63629-1507-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-1507-1367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-1507-2367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-1507-3367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63629-1507-4367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-1507-1557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-1507-2557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-1507-3557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63629-1507-4557ba5c1ecfa…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
A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENE25MG;37.5MGCAPSULE / ORALABRS1997-06-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A074821-001AB

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 22:38:342026-08A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-0584e616aacf4f…
2026-08-18 06:07:402026-07A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1997-06-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-05bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-05782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-0587673890dc5c…
2021-03-12 10:30 UTC2021-03A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-055aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1997-06-058869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1997-06-05c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1997-06-053f01610625f2…
2019-09-15 20:21 UTC2019-09A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1997-06-05b00525d2431f…
2019-07-19 19:46 UTC2019-07A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALAB1997-06-05ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-056a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-051c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-05ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-05a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-059b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-05a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-053f0d92c62455…
2023-05-13 08:27 UTC2023-05A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-05053a50430f4f…
2023-01-26 05:58 UTC2023-01A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-053bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-053a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074821-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGCAPSULE / ORALABRS1997-06-05f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A074821-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A074821-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074821-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074821-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074821-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074821-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074821-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074821-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074821-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074821-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074821-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074821-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074821-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074821-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074821-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074821-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074821-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074821-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074821-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074821-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074821-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074821-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074821-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A074821-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074821-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074821-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074821-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074821-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074821-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074821-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074821-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074821-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074821-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074821-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074821-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074821-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A074821-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A074821-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074821-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074821-001AB1f41ea6bd6efb…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1507-1EA - Each63629-1507135c4e9f-ebbe-4b24-9d83-70c05c30430a12013-02-13
63629-1507-2EA - Each63629-1507cee645af-84a7-402b-8234-e9fbbc1c6d9c12013-02-13
63629-1507-3EA - Each63629-1507761f225a-92c1-4117-9047-b13c51a4d76f12013-02-13
63629-1507-4EA - Each63629-150700f5005c-67c9-455c-9a0b-faadf5be925712013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
TRIAMTERENEACTIVE INGREDIENTWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
TRIAMTERENEACTIVE MOIETYWS821Z52LQTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
GELATININACTIVE INGREDIENT2G86QN327LTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
GLYCINEINACTIVE INGREDIENTTE7660XO1CTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
POVIDONESINACTIVE INGREDIENTFZ989GH94ETRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
SHELLACINACTIVE INGREDIENT46N107B71OTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2TRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTRIAMTERENE AND HYDROCHLOROTHIAZIDE CAPSULE [BRYANT RANCH PREPACK]1000

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDESandoz Incf824b6ba-bd1c-41a8-8f6f-ad507b48f3e02026-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074821
application number: ANDA074821
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLCdb895e64-3f97-9201-e053-2a95a90ac7ef2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074821
application number: ANDA074821
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENuCare Pharmaceuticals, Inc.3b3c92b1-bec3-2768-e063-6394a90a9af82025-07-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074821
application number: ANDA074821
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack24d40f18-b98c-48fc-8d97-5f3e351afc312024-10-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074821
application number: ANDA074821
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEA-S Medication Solutionsd3dce0c7-9e5f-49f8-bcc2-1919a30565fd2024-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074821
application number: ANDA074821
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEProficient Rx LPf11598d2-87ee-4292-8631-c29c54f4dfa92021-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074821
application number: ANDA074821

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1507-163629150701100 CAPSULE in 1 BOTTLE (63629-1507-1) 100 capsule2005-03-010000-00-00NoNoCurrent
63629-1507-26362915070230 CAPSULE in 1 BOTTLE (63629-1507-2) 30 capsule2004-12-160000-00-00NoNoCurrent
63629-1507-36362915070360 CAPSULE in 1 BOTTLE (63629-1507-3) 60 capsule2004-12-160000-00-00NoNoCurrent
63629-1507-46362915070490 CAPSULE in 1 BOTTLE (63629-1507-4) 90 capsule2008-07-030000-00-00NoNoCurrent