Home Applications 078391 Application 078391
Type ANDA
Sponsor JUBILANT CADISTA Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE CAPSULE;ORAL 12.5MG No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078391-001 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078391-001 AB
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078391-001 HYDROCHLOROTHIAZIDE 12.5MG CAPSULE / ORAL AB 2008-02-11 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 6 of 7 · 139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Hydrochlorothiazide HYDROCHLOROTHIAZIDE Proficient Rx LP ff448eb4-b48f-46f5-ac30-f03aad08f9f5 2024-03-01 Warnings, Adverse reactions Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE Hydrochlorothiazide HYDROCHLOROTHIAZIDE Bryant Ranch Prepack 78d65a02-c78e-4f98-b756-3cb5ee78f252 2024-02-20 Warnings, Adverse reactions Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE Hydrochlorothiazide HYDROCHLOROTHIAZIDE A-S Medication Solutions bd5728a2-6322-42e3-bd1e-e4915750e398 2023-12-28 Warnings, Adverse reactions Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE Hydrochlorothiazide HYDROCHLOROTHIAZIDE A-S Medication Solutions 01ad3531-5ed9-434c-b7d5-02d72aa82e46 2023-12-25 Warnings, Adverse reactions Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE Hydrochlorothiazide HYDROCHLOROTHIAZIDE Bryant Ranch Prepack 5de62aee-f3cc-4aaa-8588-2aed2bdeced9 2023-11-14 Warnings, Adverse reactions Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE Hydrochlorothiazide HYDROCHLOROTHIAZIDE A-S Medication Solutions 94cd40a1-65bc-4b1b-bb05-cec93bc96502 2023-11-01 Warnings, Adverse reactions Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE Hydrochlorothiazide HYDROCHLOROTHIAZIDE NCS HealthCare of KY, LLC dba Vangard Labs d6b933c6-f5f8-406a-84d6-b22c6040482a 2023-10-19 Warnings, Adverse reactions Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE Hydrochlorothiazide HYDROCHLOROTHIAZIDE Bryant Ranch Prepack 24cba606-263f-46dc-a4dc-fddc729c0f4b 2023-10-18 Warnings, Adverse reactions Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE Hydrochlorothiazide HYDROCHLOROTHIAZIDE Proficient Rx LP 9dd2f58b-d143-4d0c-a298-6d9390e6187a 2023-10-01 Warnings, Adverse reactions Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE Hydrochlorothiazide HYDROCHLOROTHIAZIDE A-S Medication Solutions b9e1bed7-fef9-434a-92f9-b70941176e3e 2023-09-11 Warnings, Adverse reactions Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE Hydrochlorothiazide HYDROCHLOROTHIAZIDE A-S Medication Solutions 1bb00980-eeea-4722-b010-e208f3ec2214 2023-08-24 Warnings, Adverse reactions Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE Hydrochlorothiazide HYDROCHLOROTHIAZIDE A-S Medication Solutions b56a3559-6eb2-4a8d-a9a4-232d2ff0febe 2023-06-29 Warnings, Adverse reactions Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE Hydrochlorothiazide HYDROCHLOROTHIAZIDE Proficient Rx LP 460f922c-1fda-44a5-889e-d7009883176b 2023-05-01 Warnings, Adverse reactions Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE NCS HealthCare of KY, LLC dba Vangard Labs 5605f105-f7ec-473f-8beb-9e8955e8e26e 2023-04-28 Warnings, Adverse reactions Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE Hydrochlorothiazide HYDROCHLOROTHIAZIDE Aphena Pharma Solutions - Tennessee, LLC 69c41abb-75f4-429b-905a-1ce967924aee 2023-04-04 Warnings, Adverse reactions Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE Proficient Rx LP 3464be28-5bab-4642-9d9b-8b425822dd07 2023-04-01 Warnings, Adverse reactions Name fallback brand name: HYDROCHLOROTHIAZIDE generic name: HYDROCHLOROTHIAZIDE Hydrochlorothiazide HYDROCHLOROTHIAZIDE Actavis Pharma, Inc. afdf1170-25a0-496d-b293-36ee0db2cd1e 2023-03-01 Warnings, Adverse reactions Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE Hydrochlorothiazide HYDROCHLOROTHIAZIDE A-S Medication Solutions 54224596-325d-473e-adb5-1c86857aba34 2023-02-04 Warnings, Adverse reactions Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE Hydrochlorothiazide HYDROCHLOROTHIAZIDE Proficient Rx LP c1052d38-fd75-40c2-a685-0e889009be0b 2023-02-01 Warnings, Adverse reactions Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE Hydrochlorothiazide HYDROCHLOROTHIAZIDE Proficient Rx LP c4fe84e3-c291-4220-95c1-a2bd02b1e134 2023-02-01 Warnings, Adverse reactions Name fallback brand name: Hydrochlorothiazide generic name: HYDROCHLOROTHIAZIDE
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 · 12 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 42291-315 Hydrochlorothiazide Hydrochlorothiazide AvKARE, Inc. ANDA Current 42291-315 Hydrochlorothiazide Hydrochlorothiazide AvKARE ANDA Current 50090-3186 Hydrochlorothiazide Hydrochlorothiazide A-S Medication Solutions ANDA Current 50090-3186 Hydrochlorothiazide Hydrochlorothiazide A-S Medication Solutions ANDA Current 50436-6733 Hydrochlorothiazide Hydrochlorothiazide Unit Dose Services ANDA Current 59746-382 Hydrochlorothiazide Hydrochlorothiazide JUBILANT CADISTA PHARMACEUTICALS INC. ANDA Current 59746-382 Hydrochlorothiazide Hydrochlorothiazide JUBILANT CADISTA PHARMACEUTICALS INC. ANDA Current 69375-001 Hydrochlorothiazide Hydrochlorothiazide Nationwide Pharmaceutical, LLC ANDA Current 69375-001 Hydrochlorothiazide Hydrochlorothiazide Nationwide Pharmaceutical, LLC ANDA Current 70518-0593 Hydrochlorothiazide Hydrochlorothiazide REMEDYREPACK INC. ANDA Current 70518-0593 Hydrochlorothiazide Hydrochlorothiazide REMEDYREPACK INC. ANDA Current 71610-139 Hydrochlorothiazide Hydrochlorothiazide Aphena Pharma Solutions - Tennessee, LLC ANDA Current