Application 085182

Type
ANDA
Sponsor
HERITAGE PHARMS INC

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A085182-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982
A085182-002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982
A085182-003HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A085182-001AB
A085182-002AB
A085182-003AB

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 3 of 3 · 113 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2024-02-18 07:12 UTC2024-02A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 19821c564ffb4f44…
2024-02-18 07:12 UTC2024-02A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 19821c564ffb4f44…
2024-02-18 07:12 UTC2024-02A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 19829b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 19829b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 19823f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 19823f0d92c62455…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982053a50430f4f…
2023-05-13 08:27 UTC2023-05A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 19823bdfa0b2c4d7…
2023-01-26 05:58 UTC2023-01A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 19823a93d1ddd44b…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02a50c72e98297…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 113 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A085182-001AB1c2088c7a36db…
2026-10-15 13:18:302026-09A085182-002AB1c2088c7a36db…
2026-10-15 13:18:302026-09A085182-003AB1c2088c7a36db…
2026-09-14 22:38:342026-08A085182-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A085182-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A085182-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A085182-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A085182-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A085182-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A085182-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085182-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085182-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085182-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085182-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085182-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A085182-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085182-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085182-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085182-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085182-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085182-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085182-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085182-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085182-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085182-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085182-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085182-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085182-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085182-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085182-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085182-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085182-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085182-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085182-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085182-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085182-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085182-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A085182-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A085182-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085182-001AB179d66fd596c7…

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 · 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.31a3d1cb-0f52-4818-965d-7584374bb23e2026-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.5ab641d8-cd22-4368-8070-18487dd801eb2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
ndc (product): 68788-7790
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.686a5743-adc9-4729-9dbf-5cbc2c23897a2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENorthwind Health Company, LLCc8c79657-a09a-bdb6-e053-2995a90ab6732026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
ndc (product): 51655-272
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENorthwind Health Company, LLC076017ce-8aad-1336-e063-6394a90a76b52025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HydrochlorothiazideHYDROCHLOROTHIAZIDEChartwell RX, LLC4e43dd27-3f4b-4205-a26e-6ecaa82813472025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEQPharma Incf795db5e-d5ef-4a20-e053-6394a90a7fda2025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEA-S Medication Solutions67c48f86-f412-4957-8e15-aec89e07d2952025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEA-S Medication Solutions42542233-b992-4953-87ec-5095b196d61b2025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.c59c4230-7cea-4259-9f2f-6a568716fedf2025-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
ndc (product): 23155-008
ndc (product): 23155-009
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.1570f1ad-8372-477f-89c3-8c9ce01e27d12025-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.a111cb8f-a100-a05d-e053-2995a90a020c2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
ndc (product): 68071-5211
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENCS HealthCare of KY, LLC dba Vangard Labs5605f105-f7ec-473f-8beb-9e8955e8e26e2023-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEProficient Rx LP3464be28-5bab-4642-9d9b-8b425822dd072023-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182

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 · 39 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
23155-008HydrochlorothiazideHydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
23155-008HydrochlorothiazideHydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
23155-008HydrochlorothiazideHydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
23155-008HYDROCHLOROTHIAZIDEhydrochlorothiazideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-008HYDROCHLOROTHIAZIDEhydrochlorothiazideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-008HYDROCHLOROTHIAZIDEhydrochlorothiazideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-008HYDROCHLOROTHIAZIDEhydrochlorothiazideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-008HYDROCHLOROTHIAZIDEhydrochlorothiazideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-009HydrochlorothiazideHydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
23155-009HydrochlorothiazideHydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
23155-009HydrochlorothiazideHydrochlorothiazideHeritage Pharmaceuticals Inc.ANDACurrent
23155-009HYDROCHLOROTHIAZIDEhydrochlorothiazideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-009HYDROCHLOROTHIAZIDEhydrochlorothiazideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-009HYDROCHLOROTHIAZIDEhydrochlorothiazideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-009HYDROCHLOROTHIAZIDEhydrochlorothiazideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
23155-009HYDROCHLOROTHIAZIDEhydrochlorothiazideHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ANDACurrent
51655-272HYDROCHLOROTHIAZIDEhydrochlorothiazideNorthwind Pharmaceuticals, LLCANDACurrent
60760-430HYDROCHLOROTHIAZIDEhydrochlorothiazideSt. Mary's Medical Park PharmacyANDACurrent
60760-430HYDROCHLOROTHIAZIDEhydrochlorothiazideSt. Mary's Medical Park PharmacyANDACurrent
60760-430HYDROCHLOROTHIAZIDEhydrochlorothiazideSt. Mary's Medical Park PharmacyANDACurrent
67296-1423HYDROCHLOROTHIAZIDEhydrochlorothiazideRedPharm Drug, Inc.ANDACurrent
68071-5211HydrochlorothiazideHydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5211HydrochlorothiazideHydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5266HYDROCHLOROTHIAZIDEhydrochlorothiazideNuCare PHarmaceuticals,Inc.ANDACurrent
68071-5266HYDROCHLOROTHIAZIDEhydrochlorothiazideNuCare PHarmaceuticals,Inc.ANDACurrent
68071-5273HYDROCHLOROTHIAZIDEhydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5273HYDROCHLOROTHIAZIDEhydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5284HYDROCHLOROTHIAZIDEhydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5284HYDROCHLOROTHIAZIDEhydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7648HYDROCHLOROTHIAZIDEhydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7648HYDROCHLOROTHIAZIDEhydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7648HYDROCHLOROTHIAZIDEhydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7790HYDROCHLOROTHIAZIDEhydrochlorothiazidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7790HYDROCHLOROTHIAZIDEhydrochlorothiazidePreferred Pharmaceuticals Inc.ANDACurrent
68788-7790HYDROCHLOROTHIAZIDEhydrochlorothiazidePreferred Pharmaceuticals Inc.ANDACurrent
70934-916HYDROCHLOROTHIAZIDEhydrochlorothiazideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-1716HYDROCHLOROTHIAZIDEhydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1716HYDROCHLOROTHIAZIDEhydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1716HYDROCHLOROTHIAZIDEhydrochlorothiazideBryant Ranch PrepackANDACurrent