Application 040412

Type
ANDA
Sponsor
PRINSTON INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDETABLET;ORAL25MGNoNo
002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDETABLET;ORAL50MGNoNo

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
A040412-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29
A040412-002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29

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 06:07:402026-07A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-29bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040412-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040412-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040412-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040412-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040412-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040412-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040412-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040412-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040412-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040412-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040412-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040412-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040412-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040412-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040412-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040412-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040412-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040412-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040412-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040412-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040412-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040412-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040412-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A040412-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040412-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A040412-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040412-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A040412-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040412-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A040412-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040412-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040412-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040412-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040412-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040412-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040412-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040412-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A040412-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040412-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A040412-002AB1ea1830bbd6c7…

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEAmerican Health Packagingc8de63da-b6c0-42f0-9d47-e273fe93adb32026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
ndc (product): 60687-593
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack5f2e72cc-073d-4bb5-95fe-53d4060127ec2024-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
ndc (product): 63629-1218
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack78d65a02-c78e-4f98-b756-3cb5ee78f2522024-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack24cba606-263f-46dc-a4dc-fddc729c0f4b2023-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
ndc (product): 63629-1220
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack4c3403a6-da6a-4f37-bc7e-9fe0aa2843052021-12-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
ndc (product): 63629-8992
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack0fdb6713-8013-4cfe-a776-0c1e9414a91c2020-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
ndc (product): 71335-1481
ndc (product): 71335-1451
HydrochlorothiazideHYDROCHLOROTHIAZIDESolco Healthcare U.S., LLC60c97ab9-b25e-4ea5-a159-792292178c652020-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
ndc (product): 43547-397
ndc (product): 43547-398

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 61 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0440-7595HydrochlorothiazideHydrochlorothiazideLiberty Pharmaceuticals, Inc.ANDACurrent
0615-1561HydrochlorothiazideHydrochlorothiazideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-1562HydrochlorothiazideHydrochlorothiazideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-105HydrochlorothiazideHydrochlorothiazideBlenheim Pharmacal, Inc.ANDACurrent
33261-158HydrochlorothiazideHydrochlorothiazideAidarex Pharmaceuticals LLCANDACurrent
43063-755HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-755HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-755HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-755HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-755HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-755HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-755HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-755HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-933HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, InANDACurrent
43063-933HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-933HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-933HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-933HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-933HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
43547-397HydrochlorothiazideHydrochlorothiazideSolco Healthcare U.S., LLCANDACurrent
43547-397HydrochlorothiazideHydrochlorothiazideSolco Healthcare U.S., LLCANDACurrent
43547-398HydrochlorothiazideHydrochlorothiazideSolco Healthcare U.S., LLCANDACurrent
43547-398HydrochlorothiazideHydrochlorothiazideSolco Healthcare U.S., LLCANDACurrent
50090-2213HydrochlorothiazideHydrochlorothiazideA-S Medication SolutionsANDACurrent
50090-2214HydrochlorothiazideHydrochlorothiazideA-S Medication SolutionsANDACurrent
55154-1483HydrochlorothiazideHydrochlorothiazideCardinal HealthANDACurrent
55154-1483HydrochlorothiazideHydrochlorothiazideCardinal HealthANDACurrent
55700-843HydrochlorothiazideHydrochlorothiazideQuality Care Products, LLCANDACurrent
55700-843HydrochlorothiazideHydrochlorothiazideQuality Care Products, LLCANDACurrent
60429-877HydrochlorothiazideHydrochlorothiazideGolden State Medical Supply, Inc.ANDACurrent
60429-878HydrochlorothiazideHydrochlorothiazideGolden State Medical Supply, Inc.ANDACurrent
60687-593HydrochlorothiazideHydrochlorothiazideAmerican Health PackagingANDACurrent
60687-593HydrochlorothiazideHydrochlorothiazideAmerican Health PackagingANDACurrent
63629-1121HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-1121HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-1121HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-1218HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-1218HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-1219HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-1219HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-1220HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-1220HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-8991HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-8992HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63739-128HydrochlorothiazideHydrochlorothiazideMcKesson Corporation dba SKY PackagingANDACurrent
63739-128HydrochlorothiazideHydrochlorothiazideMcKesson Corporation dba SKY PackagingANDACurrent
63739-128HydrochlorothiazideHydrochlorothiazideMcKesson CorporationANDACurrent
66336-184HydrochlorothiazideHydrochlorothiazideDispensing Solutions, Inc.ANDACurrent
67296-1682HydrochlorothiazideHydrochlorothiazideRedPharm Drug, Inc.ANDACurrent
67296-1682HydrochlorothiazideHydrochlorothiazideRedPharm Drug, Inc.ANDACurrent
67544-338HydrochlorothiazideHydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-346HydrochlorothiazideHydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
68645-341HydrochlorothiazideHydrochlorothiazideLegacy Pharmaceutical PackagingANDACurrent
68788-9919HydrochlorothiazideHydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9920HydrochlorothiazideHydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
70518-3002HydrochlorothiazideHydrochlorothiazideREMEDYREPACK INC.ANDACurrent
71335-1451HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1451HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1481HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
71610-261HydrochlorothiazideHydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
76413-139HydrochlorothiazideHydrochlorothiazideCentral Texas Community Health CentersANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
7653ORIG2003-04-09