Application 040807

Type
ANDA
Sponsor
IPCA LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDETABLET;ORAL12.5MGNoNo
002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDETABLET;ORAL25MGNoNo
003HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDETABLET;ORAL50MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040807-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGTABLET / ORAL2007-07-20
A040807-002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE25MGTABLET / ORAL2007-07-20
A040807-003HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE50MGTABLET / ORAL2007-07-20

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORAL2007-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2007-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2007-07-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORAL2007-07-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2007-07-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2007-07-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORAL2007-07-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2007-07-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2007-07-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORAL2007-07-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2007-07-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2007-07-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORAL2007-07-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2007-07-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2007-07-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORAL2007-07-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2007-07-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2007-07-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-07-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-07-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-07-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-07-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-07-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-07-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-07-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-07-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-07-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-07-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-07-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-07-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-07-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-07-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-07-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-07-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-07-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-07-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-07-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-07-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-07-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-07-208072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040807-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040807-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040807-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040807-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040807-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040807-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040807-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040807-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040807-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040807-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040807-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040807-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040807-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040807-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040807-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040807-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040807-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040807-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040807-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040807-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040807-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040807-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040807-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040807-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040807-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040807-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040807-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040807-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040807-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040807-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040807-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040807-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040807-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040807-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040807-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040807-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040807-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040807-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040807-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040807-001AB1782e0a99824c…

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 8 · 143 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.31a3d1cb-0f52-4818-965d-7584374bb23e2026-08-06Warnings, Adverse reactionsName fallback
brand name: HYDROCHLOROTHIAZIDE
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.0789baef-3424-43ab-a3fb-4908172da5652026-07-24Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDERedpharm Drug57436cfa-9b94-89bf-e063-6394a90aa2642026-07-23Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEBryant Ranch Prepack03b7e52e-0003-47c3-af12-93ef00800b372026-07-16Warnings, Adverse reactionsName fallback
brand name: HYDROCHLOROTHIAZIDE
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.cb7b7315-0170-492c-803f-60a6e75e55da2026-07-08Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEGolden State Medical Supply, Inc.a85f69f5-ba97-478d-e053-2a95a90a0a972026-07-06Warnings, Adverse reactionsName fallback
brand name: HYDROCHLOROTHIAZIDE
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEUnit Dose Solutions, Inc.54f027ea-0a6e-7920-e063-6394a90ab6ae2026-06-23Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDESt. Mary's Medical Park Pharmacy8a1de4e2-3aca-a4d3-e053-2995a90a1a412026-06-17Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDELeading Pharma, LLC8c868894-667e-4a51-906a-838d63e420ba2026-06-12Warnings, Adverse reactionsName fallback
brand name: HYDROCHLOROTHIAZIDE
generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDESt. Mary's Medical Park Pharmacy099496f1-4e2d-8d21-e063-6294a90af6952026-06-03Warnings, Adverse reactionsName fallback
brand name: HYDROCHLOROTHIAZIDE
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepacka013211e-b8f8-426d-8e55-e86193f0634e2026-05-19Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepackf22a10a2-8f84-4060-9143-427237c512802026-05-19Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack2b21f3fc-4164-401a-803e-b982dea97e192026-05-14Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.27a7e751-8aca-440e-95e4-cfecae1a24652026-05-13Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.5ab641d8-cd22-4368-8070-18487dd801eb2026-05-11Warnings, Adverse reactionsName fallback
brand name: HYDROCHLOROTHIAZIDE
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.99f45e08-897d-44dd-b48d-aa6d78981f0c2026-05-11Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals, Inc.918391e3-e8b3-4ceb-b4e7-c7c9617ea8822026-05-11Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.2fd8f595-7aec-4308-bb17-a6f2e71900442026-04-15Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepackff557069-f177-4e2e-91f4-675a033e27392026-04-14Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE
HydrochlorothiazideHYDROCHLOROTHIAZIDEAmerican Health Packagingc8de63da-b6c0-42f0-9d47-e273fe93adb32026-04-07Warnings, Adverse reactionsName fallback
brand name: Hydrochlorothiazide
generic name: HYDROCHLOROTHIAZIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-047HydrochlorothiazideHydrochlorothiazideBlenheim Pharmacal, Inc.ANDACurrent
10544-136HydrochlorothiazideHydrochlorothiazideBlenheim Pharmacal, Inc.ANDACurrent
23155-046HydrochlorothiazideHydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
23155-046HydrochlorothiazideHydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
23155-047HydrochlorothiazideHydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
23155-047HydrochlorothiazideHydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
23155-137HydrochlorothiazideHydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
23155-137HydrochlorothiazideHydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
42254-132HydrochlorothiazideHydrochlorothiazideRebel Distributors CorpANDACurrent
50436-3919HydrochlorothiazideHydrochlorothiazideUnit Dose ServicesANDACurrent
51655-126HydrochlorothiazideHydrochlorothiazideNorthwind Pharmaceuticals, LLCANDACurrent
52959-132HydrochlorothiazideHydrochlorothiazideH.J. Harkins Company, Inc.ANDACurrent
63187-074HydrochlorothiazideHydrochlorothiazideProficient Rx LPANDACurrent
63187-074HydrochlorothiazideHydrochlorothiazideProficient Rx LPANDACurrent
64725-0047HydrochlorothiazideHydrochlorothiazideTYA PharmaceuticalsANDACurrent
67046-277HydrochlorothiazideHydrochlorothiazideContract Pharmacy Services-PAANDACurrent
68788-9401HydrochlorothiazideHydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9401HydrochlorothiazideHydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent