Triamterene and Hydrochlorothiazide

Product NDC
71335-0356
11-digit product format
713350356
Labeler code
71335
Product ID
71335-0356_d129026a-42e1-4532-b5f2-5ffcb783e3bd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamterene and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA071251
Marketing category
ANDA
Marketing start
2009-09-21
Substance
HYDROCHLOROTHIAZIDE; TRIAMTERENE
Active strength
25; 37.5 mg/1; mg/1
Pharmacologic classes
Decreased Renal K+ Excretion [PE], Increased Diuresis [PE], Increased Diuresis [PE], Potassium-sparing Diuretic [EPC], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct71335-0356DDiscontinued by firm2026-08-17
excluded packagepackage71335-035671335-0356-1DDiscontinued by firm2026-08-17
excluded packagepackage71335-035671335-0356-2DDiscontinued by firm2026-08-17
excluded packagepackage71335-035671335-0356-3DDiscontinued by firm2026-08-17

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 · 56 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0356-1DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0356-3DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71335-0356-2DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0356-1DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0356-3DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71335-0356-2DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0356-1DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0356-3DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage71335-0356-2DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0356-1DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0356-3DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage71335-0356-2DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0356-1DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0356-3DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage71335-0356-2DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0356-1DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0356-3DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage71335-0356-2DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0356-1DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0356-3DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage71335-0356-2DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-0356-1DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-0356-3DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage71335-0356-2DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-0356-1DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-0356-3DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage71335-0356-2DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-0356-1DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-0356-3DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage71335-0356-2DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-0356-1DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-0356-3DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage71335-0356-2DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0356-1DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0356-3DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage71335-0356-2DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-0356-3IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-0356-1IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71335-0356-2IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-0356-3IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-0356-1IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71335-0356-2IInactivated by FDA1332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENE50MG;75MGTABLET / ORALAB1988-04-17
A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENE25MG;37.5MGTABLET / ORALAB1998-05-05

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A071251-001AB
A071251-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-17caaa826d4ba7…
2026-08-18 06:07:402026-07A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-05caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-05011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-0531067a03dcf5…
2025-08-23 18:47 UTC2025-08A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-056a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-05fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-05b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-1703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-0503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-172680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-052680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-175bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-055bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-17d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-05d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-17d06236e962d9…
2024-10-29 15:01 UTC2024-10A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-05d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-1779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-0579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-17301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-05301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-171e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-051e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-178072bd15b7f6…
2024-05-31 18:47 UTC2024-05A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-058072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-175c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-055c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-175d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-055d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-174b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-054b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-1774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-0574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071251-001TRIAMTERENE AND HYDROCHLOROTHIAZIDE50MG;75MGTABLET / ORALAB1988-04-17bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071251-002TRIAMTERENE AND HYDROCHLOROTHIAZIDE25MG;37.5MGTABLET / ORALAB1998-05-05bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A071251-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071251-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071251-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071251-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071251-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071251-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071251-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071251-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071251-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071251-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071251-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071251-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071251-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071251-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071251-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071251-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071251-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071251-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071251-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071251-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071251-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071251-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071251-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071251-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071251-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071251-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071251-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071251-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071251-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A071251-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071251-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071251-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071251-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071251-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071251-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071251-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071251-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071251-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071251-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071251-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Triamterene and Hydrochlorothiazide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRIAMTERENE25 mg/1
HYDROCHLOROTHIAZIDE37.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WS821Z52LQInternal UNII lookup
0J48LPH2THInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
310812Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ec6dce85-5c0b-475c-af0b-cbbc034f698fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
b2ea36e8-564d-01b9-8552-a327d058eb0fProduct name220200203
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0356-1Triamterene and Hydrochlorothiazide30 in 1 BOTTLETABLET30103
71335-0356-2Triamterene and Hydrochlorothiazide90 in 1 BOTTLETABLET90103
71335-0356-3Triamterene and Hydrochlorothiazide60 in 1 BOTTLETABLET60103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0356TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 3 package rows20241109_ec6dce85-5c0b-475c-af0b-cbbc034f698f.zip

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.f083c321-3170-4982-b5cd-d3fdff7548572026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071251
application number: ANDA071251
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEApotex Corp.bd6c3495-ec70-908b-482a-a979506659e92026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071251
application number: ANDA071251
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.9fe534cd-cf5f-64b4-e053-2995a90a926e2026-02-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071251
application number: ANDA071251
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLCf32b8809-80e9-18f2-e053-2995a90a54282026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071251
application number: ANDA071251
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDENorthwind Health Company, LLC9ec3d35f-b25d-48f4-926f-f093e402ccde2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071251
application number: ANDA071251
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBluePoint Laboratories4f44fb73-7f61-4623-ae89-61abd8e945ab2025-09-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071251
application number: ANDA071251
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepack5ba2c08b-5ce5-4967-bc3b-2c73df9865af2025-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071251
application number: ANDA071251
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEBryant Ranch Prepackec6dce85-5c0b-475c-af0b-cbbc034f698f2025-09-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071251
application number: ANDA071251
ndc (product): 71335-0356
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEAmerican Health Packagingba764ce4-36fe-4aa4-96a4-d0479b875b4f2025-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071251
application number: ANDA071251
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC15e6f934-fe66-4640-bdf1-13b389cd9e542023-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071251
application number: ANDA071251
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLCb129e54a-a6d8-42c0-baac-e8db2487369b2021-11-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071251
application number: ANDA071251
Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC191b9e48-7d44-4378-9f3f-b4a999080c8c2020-11-12Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071251
application number: ANDA071251

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310812triamterene 37.5 MG / hydroCHLOROthiazide 25 MG Oral TabletPSNec6dce85-5c0b-475c-af0b-cbbc034f698f103
310812hydrochlorothiazide 25 MG / triamterene 37.5 MG Oral TabletSCDec6dce85-5c0b-475c-af0b-cbbc034f698f103
310812HCTZ 25 MG / triamterene 37.5 MG Oral TabletSYec6dce85-5c0b-475c-af0b-cbbc034f698f103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0356-17133503560130 TABLET in 1 BOTTLE (71335-0356-1) 30 tablet2018-03-050000-00-00NoNoCurrent
71335-0356-27133503560290 TABLET in 1 BOTTLE (71335-0356-2) 90 tablet2018-03-210000-00-00NoNoCurrent
71335-0356-37133503560360 TABLET in 1 BOTTLE (71335-0356-3) 60 tablet2024-10-300000-00-00NoNoCurrent