Triamterene and Hydrochlorothiazide

Product NDC
68788-7893
11-digit product format
687887893
Labeler code
68788
Product ID
68788-7893_45dd0b88-02b3-40a1-82cb-724316468798
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Triamterene and Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA071251
Marketing category
ANDA
Marketing start
2021-04-26
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE; TRIAMTERENE
Active strength
25 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
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 productproduct68788-7893DDiscontinued by firm2026-08-17
excluded packagepackage68788-789368788-7893-1DDiscontinued by firm2026-08-17
excluded packagepackage68788-789368788-7893-3DDiscontinued by firm2026-08-17
excluded packagepackage68788-789368788-7893-6DDiscontinued by firm2026-08-17
excluded packagepackage68788-789368788-7893-9DDiscontinued 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 · 5 matching rows.

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

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage68788-7893-3
excluded packagepackage68788-7893-1
excluded packagepackage68788-7893-9
excluded packagepackage68788-7893-6

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7893-1EA - Each68788-789339db3301-944a-4b9a-adca-005ddda7287412021-06-02
68788-7893-3EA - Each68788-789333ba4a3e-78ca-4c61-ad50-c5a6d7a9edc312021-06-02
68788-7893-6EA - Each68788-7893140dda68-ed9b-4f23-adf7-6c9da76553be12021-06-02
68788-7893-9EA - Each68788-7893694747ca-9028-44be-b742-cd12ab77fc4712021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7893TRIAMTERENE AND HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS INC.]4Legacy NDC20240823_621062c2-9d8d-4441-8f37-695512cafb35.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7893-168788789301100 TABLET in 1 BOTTLE (68788-7893-1) 100 tablet2021-04-260000-00-00NoNoCurrent
68788-7893-36878878930330 TABLET in 1 BOTTLE (68788-7893-3) 30 tablet2021-04-260000-00-00NoNoCurrent
68788-7893-66878878930660 TABLET in 1 BOTTLE (68788-7893-6) 60 tablet2021-04-260000-00-00NoNoCurrent
68788-7893-96878878930990 TABLET in 1 BOTTLE (68788-7893-9) 90 tablet2021-04-260000-00-00NoNoCurrent