Hydrochlorothiazide

Product NDC
63187-074
11-digit product format
631870074
Labeler code
63187
Product ID
63187-074_2d8c4763-f719-46ce-8fb8-04e82fbacf05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA040807
Marketing category
ANDA
Marketing start
2010-08-20
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE
Active strength
25 mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63187-074DDiscontinued by firm2026-08-11
excluded packagepackage63187-07463187-074-30DDiscontinued by firm2026-08-11
excluded packagepackage63187-07463187-074-90DDiscontinued by firm2026-08-11

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 · 6 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 packagepackage63187-074-90d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage63187-074-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-074-90f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63187-074-30f5e01cc5f278…a2eaf40c39c3…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040807-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGTABLET / ORAL2007-07-20
A040807-002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE25MGTABLET / ORAL2007-07-20
A040807-003HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE50MGTABLET / ORAL2007-07-20

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 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORAL2007-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2007-07-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2007-07-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORAL2007-07-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2007-07-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2007-07-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORAL2007-07-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2007-07-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2007-07-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORAL2007-07-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2007-07-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2007-07-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORAL2007-07-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2007-07-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2007-07-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORAL2007-07-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2007-07-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2007-07-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-07-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-07-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-07-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-07-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-07-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-07-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-07-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-07-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-07-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-07-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-07-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-07-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-07-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-07-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-07-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-07-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-07-20301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-07-20301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-07-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040807-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2007-07-201e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040807-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2007-07-201e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040807-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2007-07-208072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 102 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040807-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040807-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040807-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040807-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040807-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040807-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040807-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040807-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040807-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040807-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040807-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040807-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040807-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040807-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040807-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040807-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040807-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040807-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040807-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040807-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040807-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040807-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040807-002AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040807-003AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040807-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040807-002AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040807-003AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040807-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040807-002AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040807-003AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040807-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040807-002AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040807-003AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040807-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040807-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040807-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040807-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040807-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040807-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040807-001AB1782e0a99824c…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-074HYDROCHLOROTHIAZIDE TABLET [PROFICIENT RX LP]4Legacy NDC20191121_7288899f-f4a8-454d-b407-23494cc9118f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-074-306318700743030 TABLET in 1 BOTTLE (63187-074-30) 30 tablet2018-11-010000-00-00NoNoCurrent
63187-074-906318700749090 TABLET in 1 BOTTLE (63187-074-90) 90 tablet2018-11-010000-00-00NoNoCurrent