Hydrochlorothiazide

Product NDC
68071-2456
Requested package NDC
68071-2456-1
11-digit product format
680712456
Labeler code
68071
Product ID
68071-2456_c55fd54a-b01b-44ec-e053-2a95a90a82e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA202556
Marketing category
ANDA
Marketing start
2013-04-18
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE
Active strength
13 mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
2022-12-31
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 packagepackage68071-245668071-2456-1DDiscontinued 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 · 15 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…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

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
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 · 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 UTC2026-02A202556-001HYDROCHLOROTHIAZIDE12.5MGTABLET / 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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202556-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2012-09-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202556-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2012-09-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202556-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALABRS2012-09-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202556-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2012-09-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202556-003HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2012-09-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202556-001HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALABRS2012-09-248072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202556-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A202556-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202556-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202556-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A202556-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A202556-001AB18072bd15b7f6…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2456-12023-01-30C16284748780-1f386c649-f4ed-0266-e053-dadaa90a7c1aHYDROCHLOROTHIAZIDE TABLETS, USP 12.5 mg, 25 mg and 50 mg Rx only

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2456HYDROCHLOROTHIAZIDE TABLET [NUCARE PHARMACEUTICALS,INC.]1Legacy NDC20210623_c55fd90f-1e34-557d-e053-2a95a90ab2f5.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 · 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
68071-2456-168071245601100 TABLET in 1 BOTTLE (68071-2456-1) 100 tablet2021-06-220000-00-00NoNoCurrent