Hydrochlorothiazide

Product NDC
68788-8928
Requested package NDC
68788-8928-9
11-digit product format
687888928
Labeler code
68788
Product ID
68788-8928_fdf0a5ec-f354-42e5-a164-adc8235bda75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA202556
Marketing category
ANDA
Marketing start
2015-10-07
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE
Active strength
50 mg/1
Pharmacologic classes
Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68788-892868788-8928-9DDiscontinued by firm2026-10-05

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 43.

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
A202556-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2012-09-24
A202556-002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2012-09-24
A202556-003HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2012-09-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A202556-001AB
A202556-002AB
A202556-003AB

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A202556-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2012-09-2484e616aacf4f…
2026-09-14 22:38:342026-08A202556-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2012-09-2484e616aacf4f…
2026-09-14 22:38:342026-08A202556-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2012-09-2484e616aacf4f…
2026-08-18 06:07:402026-07A202556-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2012-09-24caaa826d4ba7…
2026-08-18 06:07:402026-07A202556-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2012-09-24caaa826d4ba7…
2026-08-18 06:07:402026-07A202556-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2012-09-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202556-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2012-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202556-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2012-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202556-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2012-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202556-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2012-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202556-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2012-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202556-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2012-09-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A202556-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2012-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202556-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2012-09-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202556-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2012-09-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202556-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2012-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202556-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2012-09-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202556-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2012-09-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202556-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2012-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202556-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2012-09-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202556-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2012-09-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202556-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2012-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202556-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2012-09-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202556-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2012-09-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202556-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2012-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202556-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2012-09-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202556-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2012-09-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202556-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALABRS2012-09-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202556-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2012-09-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202556-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2012-09-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202556-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALABRS2012-09-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202556-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2012-09-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202556-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2012-09-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202556-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALABRS2012-09-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A202556-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2012-09-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A202556-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2012-09-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202556-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALABRS2012-09-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202556-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2012-09-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202556-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2012-09-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202556-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALABRS2012-09-24301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A202556-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A202556-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A202556-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A202556-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202556-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A202556-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A202556-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202556-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A202556-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202556-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202556-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A202556-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A202556-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202556-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A202556-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202556-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202556-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A202556-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202556-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202556-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A202556-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202556-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202556-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A202556-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202556-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202556-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A202556-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202556-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202556-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A202556-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202556-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202556-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A202556-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A202556-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202556-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A202556-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202556-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202556-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A202556-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202556-001AB1301d65b070ca…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrochlorothiazideACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1
HydrochlorothiazideACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPHYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2HYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [PREFERRED PHARMACEUTICALS INC.]1

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 · 18 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepacka013211e-b8f8-426d-8e55-e86193f0634e2026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202556
application number: ANDA202556
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepackf22a10a2-8f84-4060-9143-427237c512802026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202556
application number: ANDA202556
HydrochlorothiazideHYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.27a7e751-8aca-440e-95e4-cfecae1a24652026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202556
application number: ANDA202556
HydrochlorothiazideHYDROCHLOROTHIAZIDEAccord Healthcare Inc.babb1b20-fe82-40ba-8e7a-0c56fe433b4a2026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202556
application number: ANDA202556
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.c2db7e27-952f-c3f6-e053-2995a90af7c12026-03-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202556
application number: ANDA202556
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.c2d993ff-b11b-7a62-e053-2995a90a0b002026-03-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202556
application number: ANDA202556
HydrochlorothiazideHYDROCHLOROTHIAZIDENorthwind Health Company, LLC57a2f9bd-8ca5-437e-b911-5207f94cc6ba2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202556
application number: ANDA202556
HydrochlorothiazideHYDROCHLOROTHIAZIDENorthwind Health Company, LLCab8115a0-e96f-7aee-e053-2995a90a6ec02026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202556
application number: ANDA202556
HydrochlorothiazideHYDROCHLOROTHIAZIDENorthwind Health Company, LLCf3191ca2-4dbc-01f5-e053-2a95a90a572c2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202556
application number: ANDA202556
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEDIRECT RXcbe5e01e-67ca-f8a2-e053-2995a90a0d152025-01-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202556
application number: ANDA202556
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals, Inc.3e35fb03-9173-6731-e054-00144ff8d46c2024-08-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202556
application number: ANDA202556
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals, Inc.53fe1730-a803-26b2-e054-00144ff88e882024-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202556
application number: ANDA202556
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions98a58b54-bcf2-4726-800a-facf48d9155f2024-04-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202556
application number: ANDA202556
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack5de62aee-f3cc-4aaa-8588-2aed2bdeced92023-11-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202556
application number: ANDA202556
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions54224596-325d-473e-adb5-1c86857aba342023-02-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202556
application number: ANDA202556
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LP48b4d633-ecfa-4748-80e8-6c0e3d8b067e2022-05-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202556
application number: ANDA202556
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LPfd9b3e5a-f564-4730-8b9f-2cdc2953cbc92022-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202556
application number: ANDA202556
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LP78c04f59-65c3-4a16-83a6-ed4a409afce52021-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 202556
application number: ANDA202556

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8928-96878889280990 TABLET in 1 BOTTLE (68788-8928-9) 90 tablet2015-10-070000-00-00NoNoCurrent