Hydrochlorothiazide

Product NDC
60429-888
Requested package NDC
60429-888-01
11-digit product format
604290888
Labeler code
60429
Product ID
60429-888_ebcd382d-5637-585c-e053-2995a90aa86c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply
Application
ANDA040707
Marketing category
ANDA
Marketing start
2007-02-27
Marketing end
2023-03-31
Substance
HYDROCHLOROTHIAZIDE
Active strength
13 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60429-88860429-888-01DDiscontinued by firm2026-08-07

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040707-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040707-001AB

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-2787673890dc5c…
2021-03-12 10:30 UTC2021-03A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-275aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-278869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-273f01610625f2…
2019-09-15 20:21 UTC2019-09A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27b00525d2431f…
2019-07-19 19:46 UTC2019-07A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-276a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-271c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-279b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-273f0d92c62455…
2023-05-13 08:27 UTC2023-05A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27053a50430f4f…
2023-01-26 05:58 UTC2023-01A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-273bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-273a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040707-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-02-27cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040707-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040707-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040707-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040707-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040707-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040707-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040707-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040707-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040707-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040707-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040707-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040707-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040707-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040707-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040707-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040707-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040707-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040707-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040707-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040707-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040707-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040707-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040707-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040707-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040707-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040707-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040707-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040707-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040707-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040707-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040707-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040707-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040707-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040707-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040707-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040707-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040707-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040707-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040707-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040707-001AB1cb3db0bc1861…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-888-01EA - Each60429-8882397948d-86a7-453f-abac-cd617023f40312017-11-06

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.fea5a353-9b13-9b87-e053-6394a90a627d2025-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040707
application number: ANDA040707
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions01ad3531-5ed9-434c-b7d5-02d72aa82e462023-12-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040707
application number: ANDA040707
HydrochlorothiazideHYDROCHLOROTHIAZIDEActavis Pharma, Inc.afdf1170-25a0-496d-b293-36ee0db2cd1e2023-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040707
application number: ANDA040707

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60429-888-0160429088801100 TABLET in 1 BOTTLE (60429-888-01) 100 tablet2017-06-082023-03-31NoNoCurrent