Application 203561

Type
ANDA
Sponsor
SCIEGEN PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDECAPSULE;ORAL12.5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A203561-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203561-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-1487673890dc5c…
2021-03-12 10:30 UTC2021-03A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-143f01610625f2…
2019-09-15 20:21 UTC2019-09A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14b00525d2431f…
2019-07-19 19:46 UTC2019-07A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-143f0d92c62455…
2023-05-13 08:27 UTC2023-05A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14053a50430f4f…
2023-01-26 05:58 UTC2023-01A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203561-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2019-01-14e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A203561-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203561-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203561-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203561-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203561-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203561-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203561-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203561-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203561-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203561-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203561-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203561-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203561-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203561-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203561-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203561-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203561-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203561-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203561-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203561-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203561-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203561-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A203561-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203561-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203561-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203561-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A203561-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203561-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203561-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203561-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203561-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203561-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203561-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203561-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203561-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203561-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203561-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203561-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203561-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A203561-001AB1e64feba35796…

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 · 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.0789baef-3424-43ab-a3fb-4908172da5652026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203561
application number: ANDA203561
ndc (product): 70518-2550
HydrochlorothiazideHYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.cb7b7315-0170-492c-803f-60a6e75e55da2026-07-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203561
application number: ANDA203561
ndc (product): 72789-176
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack2b21f3fc-4164-401a-803e-b982dea97e192026-05-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203561
application number: ANDA203561
ndc (product): 71335-1713
HydrochlorothiazideHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals, Inc.918391e3-e8b3-4ceb-b4e7-c7c9617ea8822026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203561
application number: ANDA203561
ndc (product): 68788-7683
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepackff557069-f177-4e2e-91f4-675a033e27392026-04-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203561
application number: ANDA203561
ndc (product): 63629-8498
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack45316037-52ec-438f-8780-b2e983fef3f52026-03-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203561
application number: ANDA203561
HydrochlorothiazideHYDROCHLOROTHIAZIDEWestminster Pharmaceuticals, LLC0fc94bc2-fa38-439a-a609-1b4130cdacb12026-03-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203561
application number: ANDA203561
ndc (product): 69367-219
HydrochlorothiazideHYDROCHLOROTHIAZIDEScieGen Pharmaceuticals Inc911a18c1-120a-46b3-b7a8-25eb378434732026-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203561
application number: ANDA203561
ndc (product): 50228-146
HydrochlorothiazideHYDROCHLOROTHIAZIDEAvPAKef56450d-86d3-2654-e053-2995a90a142c2026-01-08Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203561
application number: ANDA203561
ndc (product): 50268-404
HydrochlorothiazideHYDROCHLOROTHIAZIDENorthwind Health Company, LLCf32ce8fe-6cbc-8a15-e053-2995a90a8eec2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203561
application number: ANDA203561
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions02a481cb-ad80-41bb-82d3-c237b00ed8d72025-05-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203561
application number: ANDA203561
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutionsbd5728a2-6322-42e3-bd1e-e4915750e3982023-12-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203561
application number: ANDA203561
HydrochlorothiazideHYDROCHLOROTHIAZIDENCS HealthCare of KY, LLC dba Vangard Labsd6b933c6-f5f8-406a-84d6-b22c6040482a2023-10-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203561
application number: ANDA203561
ndc (product): 0615-8344
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LP460f922c-1fda-44a5-889e-d7009883176b2023-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203561
application number: ANDA203561
ndc (product): 71205-589
HydrochlorothiazideHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLC69c41abb-75f4-429b-905a-1ce967924aee2023-04-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203561
application number: ANDA203561
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LPb54ec2b1-3325-46a1-b654-8a75dc41ab0a2022-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203561
application number: ANDA203561
ndc (product): 71205-980
HydrochlorothiazideHYDROCHLOROTHIAZIDEAphena Pharma Solutions - Tennessee, LLCf0b993f2-9771-42e3-b10e-09719189e2bd2021-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203561
application number: ANDA203561
ndc (product): 71610-500

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8344HydrochlorothiazideHydrochlorothiazideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
50228-146HydrochlorothiazideHydrochlorothiazideScieGen Pharmaceuticals IncANDACurrent
50228-146HydrochlorothiazideHydrochlorothiazideScieGen Pharmaceuticals IncANDACurrent
50228-146HydrochlorothiazideHydrochlorothiazideScieGen Pharmaceuticals IncANDACurrent
50268-404HydrochlorothiazideHydrochlorothiazideAvPAKANDACurrent
63629-8498HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
63629-8498HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
68071-2654HydrochlorothiazideHydrochlorothiazideNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7683HydrochlorothiazideHydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7683HydrochlorothiazideHydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
68788-7683HydrochlorothiazideHydrochlorothiazidePreferred Pharmaceuticals, Inc.ANDACurrent
69367-219HydrochlorothiazideHydrochlorothiazideWestminster PharmaceuticalsANDACurrent
69367-219HydrochlorothiazideHydrochlorothiazideWestminster PharmaceuticalsANDACurrent
69367-219HydrochlorothiazideHydrochlorothiazideWestminster PharmaceuticalsANDACurrent
70518-2550HydrochlorothiazideHydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2550HydrochlorothiazideHydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2550HydrochlorothiazideHydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2550HydrochlorothiazideHydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70518-2550HydrochlorothiazideHydrochlorothiazideREMEDYREPACK INC.ANDACurrent
70934-930HydrochlorothiazideHydrochlorothiazideDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71205-589HydrochlorothiazideHydrochlorothiazideProficient Rx LPANDACurrent
71205-980HydrochlorothiazideHydrochlorothiazideProficient Rx LPANDACurrent
71205-980HydrochlorothiazideHydrochlorothiazideProficient Rx LPANDACurrent
71205-980HydrochlorothiazideHydrochlorothiazideProficient Rx LPANDACurrent
71335-1713HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1713HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
71335-1713HydrochlorothiazideHydrochlorothiazideBryant Ranch PrepackANDACurrent
71610-500HydrochlorothiazideHydrochlorothiazideAphena Pharma Solutions - Tennessee, LLCANDACurrent
72789-176HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-176HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-176HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent
72789-176HydrochlorothiazideHydrochlorothiazidePD-Rx Pharmaceuticals, Inc.ANDACurrent