Hydrochlorothiazide

Product NDC
63739-128
11-digit product format
637390128
Labeler code
63739
Product ID
63739-128_b3d6d2a8-97a2-5bad-e053-2a95a90a155d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA040412
Marketing category
ANDA
Marketing start
2002-03-29
Marketing end
2021-05-31
Substance
HYDROCHLOROTHIAZIDE
Active strength
25 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63739-128DDiscontinued by firm2026-08-17
excluded packagepackage63739-12863739-128-10DDiscontinued by firm2026-08-17

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63739-128-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63739-128-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63739-128-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63739-128-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63739-128-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63739-128-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63739-128-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63739-128-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63739-128-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63739-128-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63739-128-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63739-128-10557ba5c1ecfa…9c80585c8c6e…

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040412-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29
A040412-002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29caaa826d4ba7…
2026-08-18 06:07:402026-07A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-298072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-295c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-295c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-295d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-295d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-294b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-294b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-2974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-2974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2002-03-29bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2002-03-29bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040412-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040412-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040412-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040412-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040412-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040412-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040412-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040412-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040412-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040412-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040412-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040412-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040412-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040412-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040412-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040412-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040412-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040412-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040412-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040412-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040412-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040412-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040412-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A040412-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040412-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A040412-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040412-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A040412-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040412-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A040412-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040412-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040412-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040412-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040412-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040412-001AB16a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040412-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040412-001AB11c564ffb4f44…
2024-02-18 07:12 UTC2024-02A040412-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040412-001AB1ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12A040412-002AB1ea1830bbd6c7…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-128-102020-07-22C16284748780-1ab0e2407-358a-f274-e053-dbdaa90a6471HYDROCHLOROTHIAZIDE TABLETS, USP 25 mg and 50 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-128-10EA - Each63739-128001bdba0-8b72-4c2b-a012-3461faeaa64612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrochlorothiazideACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [CARDINAL HEALTH]3
hydrochlorothiazideACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [CARDINAL HEALTH]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCHLOROTHIAZIDE TABLET [CARDINAL HEALTH]3
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [CARDINAL HEALTH]3
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [CARDINAL HEALTH]3
magnesium stearateINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [CARDINAL HEALTH]3
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCHLOROTHIAZIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2

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 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEAmerican Health Packagingc8de63da-b6c0-42f0-9d47-e273fe93adb32026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack5f2e72cc-073d-4bb5-95fe-53d4060127ec2024-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack78d65a02-c78e-4f98-b756-3cb5ee78f2522024-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack24cba606-263f-46dc-a4dc-fddc729c0f4b2023-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack4c3403a6-da6a-4f37-bc7e-9fe0aa2843052021-12-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack0fdb6713-8013-4cfe-a776-0c1e9414a91c2020-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDESolco Healthcare U.S., LLC60c97ab9-b25e-4ea5-a159-792292178c652020-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-128-106373901281010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-128-10) > 10 TABLET in 1 BLISTER PACK10 blister pack2002-03-292021-05-31NoNoCurrent