HYDROCHLOROTHIAZIDE

Product NDC
68071-5284
Requested package NDC
68071-5284-1
11-digit product format
680715284
Labeler code
68071
Product ID
68071-5284_dfc93cb0-dd47-7d7e-e053-2a95a90a5ef1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA085182
Marketing category
ANDA
Marketing start
2015-01-15
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 packagepackage68071-528468071-5284-1DDiscontinued 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 · 13 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03DDiscontinued by firm367a005e9d99…383a685ebd0f…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…

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
A085182-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982
A085182-002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982
A085182-003HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A085182-001AB
A085182-002AB
A085182-003AB

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 3 · 104 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 198231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 19826a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 198203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 19822680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 19825bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982d06236e962d9…
2024-10-29 15:01 UTC2024-10A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 198279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 1982301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085182-002HYDROCHLOROTHIAZIDE25MGTABLET / ORALABApproved before 19821e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085182-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2023-05-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085182-001HYDROCHLOROTHIAZIDE50MGTABLET / ORALABApproved before 19828072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 104 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A085182-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085182-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A085182-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085182-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085182-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A085182-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A085182-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085182-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A085182-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085182-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085182-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A085182-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085182-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085182-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A085182-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085182-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085182-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A085182-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085182-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085182-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A085182-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085182-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085182-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A085182-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085182-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085182-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A085182-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A085182-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A085182-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A085182-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085182-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085182-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A085182-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085182-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085182-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A085182-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085182-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085182-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A085182-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A085182-001AB18072bd15b7f6…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-5284-12022-05-25C16284748780-1d6a99b39-74de-a426-e053-dadaa90af4c2HYDROCHLOROTHIAZIDE TABLETS, USP Rx only
68071-5284-12022-01-28C16284748780-1d6a99b39-74de-a426-e053-dadaa90af4c2HYDROCHLOROTHIAZIDE TABLETS, USP Rx only

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.31a3d1cb-0f52-4818-965d-7584374bb23e2026-08-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.5ab641d8-cd22-4368-8070-18487dd801eb2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.686a5743-adc9-4729-9dbf-5cbc2c23897a2026-01-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENorthwind Health Company, LLCc8c79657-a09a-bdb6-e053-2995a90ab6732026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENorthwind Health Company, LLC076017ce-8aad-1336-e063-6394a90a76b52025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HydrochlorothiazideHYDROCHLOROTHIAZIDEChartwell RX, LLC4e43dd27-3f4b-4205-a26e-6ecaa82813472025-12-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEQPharma Incf795db5e-d5ef-4a20-e053-6394a90a7fda2025-12-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.1fad059f-f030-4dd8-b02a-bf3e775d37d22025-11-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEA-S Medication Solutions67c48f86-f412-4957-8e15-aec89e07d2952025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEA-S Medication Solutions42542233-b992-4953-87ec-5095b196d61b2025-11-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.c59c4230-7cea-4259-9f2f-6a568716fedf2025-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEREMEDYREPACK INC.1570f1ad-8372-477f-89c3-8c9ce01e27d12025-05-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.a111cb8f-a100-a05d-e053-2995a90a020c2024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDENCS HealthCare of KY, LLC dba Vangard Labs5605f105-f7ec-473f-8beb-9e8955e8e26e2023-04-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182
HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDEProficient Rx LP3464be28-5bab-4642-9d9b-8b425822dd072023-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 085182
application number: ANDA085182

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5284-168071528401100 TABLET in 1 BOTTLE (68071-5284-1) 100 tablet2020-06-180000-00-00NoNoCurrent