Home NDC 0228-2820-96 Hydrochlorothiazide
Product NDC 0228-2820
Requested package NDC 0228-2820-96
11-digit product format 002282820
Labeler code 0228
Product ID 0228-2820_2b5bc2c3-8d3c-43c8-8e4c-e44aca5624cd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Hydrochlorothiazide
Dosage form TABLET
Route ORAL
Labeler Actavis Pharma, Inc.
Application ANDA040707
Marketing category ANDA
Marketing start 2007-03-12
Marketing end 2027-06-30
Substance HYDROCHLOROTHIAZIDE
Active strength 12.5 mg/1
Pharmacologic classes Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag No
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A040707-001 HYDROCHLOROTHIAZIDE HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A040707-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A040707-001 HYDROCHLOROTHIAZIDE 12.5MG TABLET / ORAL AB 2007-02-27 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Hydrochlorothiazide Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCHLOROTHIAZIDE 12.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0J48LPH2TH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 429503 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0228-2820-11 Hydrochlorothiazide 100 in 1 BOTTLE TABLET 100 14 0228-2820-96 Hydrochlorothiazide 1000 in 1 BOTTLE TABLET 1000 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH HYDROCHLOROTHIAZIDE TABLET [ACTAVIS ELIZABETH LLC] 4 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH HYDROCHLOROTHIAZIDE TABLET [ACTAVIS ELIZABETH LLC] 4 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L HYDROCHLOROTHIAZIDE TABLET [ACTAVIS ELIZABETH LLC] 4 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HYDROCHLOROTHIAZIDE TABLET [ACTAVIS ELIZABETH LLC] 4 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROCHLOROTHIAZIDE TABLET [ACTAVIS ELIZABETH LLC] 4 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J HYDROCHLOROTHIAZIDE TABLET [ACTAVIS ELIZABETH LLC] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HYDROCHLOROTHIAZIDE TABLET [ACTAVIS ELIZABETH LLC] 4 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP HYDROCHLOROTHIAZIDE TABLET [ACTAVIS ELIZABETH LLC] 4 HYDROCHLOROTHIAZIDE ACTIVE INGREDIENT 0J48LPH2TH HYDROCHLOROTHIAZIDE TABLET [MED-HEALTH PHARMA, LLC] 2 HYDROCHLOROTHIAZIDE ACTIVE MOIETY 0J48LPH2TH HYDROCHLOROTHIAZIDE TABLET [MED-HEALTH PHARMA, LLC] 2 CALCIUM STEARATE INACTIVE INGREDIENT 776XM7047L HYDROCHLOROTHIAZIDE TABLET [MED-HEALTH PHARMA, LLC] 2 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HYDROCHLOROTHIAZIDE TABLET [MED-HEALTH PHARMA, LLC] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X HYDROCHLOROTHIAZIDE TABLET [MED-HEALTH PHARMA, LLC] 2 SODIUM LAURYL SULFATE INACTIVE INGREDIENT 368GB5141J HYDROCHLOROTHIAZIDE TABLET [MED-HEALTH PHARMA, LLC] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HYDROCHLOROTHIAZIDE TABLET [MED-HEALTH PHARMA, LLC] 2 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP HYDROCHLOROTHIAZIDE TABLET [MED-HEALTH PHARMA, LLC] 2 Hydrochlorothiazide ACTIVE INGREDIENT 0J48LPH2TH HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP] 1 Hydrochlorothiazide ACTIVE MOIETY 0J48LPH2TH HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP] 1 calcium stearate INACTIVE INGREDIENT 776XM7047L HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP] 1 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP] 1 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP] 1 stearic acid INACTIVE INGREDIENT 4ELV7Z65AP HYDROCHLOROTHIAZIDE TABLET [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0228-2820 HYDROCHLOROTHIAZIDE TABLET [ACTAVIS PHARMA, INC.] 12 Current NDC, Legacy NDC, 2 package rows 20231202_afdf1170-25a0-496d-b293-36ee0db2cd1e.zip
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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0228-2820-96 00228282096 1000 TABLET in 1 BOTTLE (0228-2820-96) 1000 tablet 2023-12-01 2027-06-30 No No Historical