Application 074821

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIAMTERENE AND HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE; TRIAMTERENECAPSULE;ORAL25MG;37.5MGNoNo

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…

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
ndc (product): 0781-2074
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
ndc (product): 63629-8732
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
ndc (product): 63187-465

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-2074Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideSandoz IncANDACurrent
0781-2074Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideSandoz IncANDACurrent
0781-2074Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideSandoz IncANDACurrent
0781-2074Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideSandoz IncANDACurrent
0781-2074Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideSandoz IncANDACurrent
0781-2074Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideSandoz IncANDACurrent
21695-839Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideRebel Distributors CorpANDACurrent
35356-974Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-974Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideQuality Care Products LLCANDACurrent
35356-974Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-974Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-974Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideLake Erie Medical DBA Quality Care Products LLCANDACurrent
35356-974Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideLake Erie Medical DBA Quality Care Products LLCANDACurrent
45865-402Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideMedsource PharmaceuticalsANDACurrent
45865-402Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideMedsource PharmaceuticalsANDACurrent
50090-0523Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideA-S Medication SolutionsANDACurrent
53808-0803Triamterene and HydrochlorothiazideTRIAMTERENE AND HYDROCHLOROTHIAZIDEState of Florida DOH Central PharmacyANDACurrent
63187-465Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideProficient Rx LPANDACurrent
63187-465Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideProficient Rx LPANDACurrent
63629-1507Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-1507Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-1507Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-8732Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-8732Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-8732Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideBryant Ranch PrepackANDACurrent
70934-554Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-554Triamterene and HydrochlorothiazideTriamterene and HydrochlorothiazideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent