Hydrochlorothiazide

Product NDC
70934-789
Requested package NDC
70934-789-30
11-digit product format
709340789
Labeler code
70934
Product ID
70934-789_c181aebd-b0a9-d302-e053-2a95a90a8e52
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application
ANDA040907
Marketing category
ANDA
Marketing start
2020-08-18
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
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 packagepackage70934-78970934-789-30DDiscontinued 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 · 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 42.

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
A040907-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-15
A040907-002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-15
A040907-003HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2025-04-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040907-001AB
A040907-002AB
A040907-003AB

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 · 89 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-15caaa826d4ba7…
2026-08-18 06:07:402026-07A040907-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2025-04-03caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-15011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040907-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2025-04-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-1531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040907-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2025-04-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-156a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040907-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2025-04-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-15fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-15b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-1503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-152680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-155bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-15d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-15d06236e962d9…
2024-10-29 15:01 UTC2024-10A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-1579d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-15301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-151e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-158072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-155c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-155d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-154b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-154b0b4de00fa7…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 89 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A040907-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040907-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A040907-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040907-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040907-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040907-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040907-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040907-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040907-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040907-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040907-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040907-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040907-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040907-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040907-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040907-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040907-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040907-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040907-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040907-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040907-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040907-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040907-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040907-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040907-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040907-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040907-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040907-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040907-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040907-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040907-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040907-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040907-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A040907-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040907-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040907-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040907-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A040907-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040907-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A040907-002AB14b0b4de00fa7…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-789-30EA - Each70934-789109b7bcc-ff6c-4704-a7b0-20f052e0075612022-12-07
70934-789-90EA - Each70934-789e59ae927-9709-45ed-8be1-bb2076b65cc912022-12-07

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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEUnit Dose Solutions, Inc.54f027ea-0a6e-7920-e063-6394a90ab6ae2026-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDESt. Mary's Medical Park Pharmacy8a1de4e2-3aca-a4d3-e053-2995a90a1a412026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.99f45e08-897d-44dd-b48d-aa6d78981f0c2026-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEREMEDYREPACK INC.2fd8f595-7aec-4308-bb17-a6f2e71900442026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDECoupler LLC4ee35bcf-1eb0-1cca-e063-6294a90adeed2026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEAmerican Health Packaging2ec371a5-18ba-4ce2-9725-7f99bb73454a2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions96838fd0-ad87-4b45-b2c0-efdd1d2f3d1e2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutions088cb67f-3eaa-4e78-9fbe-ad2d6b7c57072026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEA-S Medication Solutionsf1f99065-04d2-48ac-b25d-9595237c869c2026-02-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDENorthwind Health Company, LLCf2f3b60a-bffe-2675-e053-2995a90ae96e2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEQPharma, Inc.9cd5d16e-3db7-4b25-847d-6de91543463b2025-12-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEPD-Rx Pharmaceuticals, Inc.67bedecc-f758-4bc6-82c5-7d428cbbbd9b2025-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepackd7d0867a-748e-4960-851f-ad764e07f7742025-08-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack73bc116a-2964-4acc-9ef0-0a3f662689132025-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEUnichem Pharmaceuticals (USA), Inc.33f3b980-b339-4dbf-99bd-05588c2a298c2025-06-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDERedpharm drugfa1c0b92-4360-bcfd-e053-6394a90a955a2025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEDirect_Rx05156717-fe1b-22f1-e063-6394a90a3d102025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDELake Erie Medical DBA Quality Care Products LLC9e6a0c83-1494-44ca-90e0-3f43fa8ec7462024-12-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDENuCare Pharmaceuticals,Inc.8bc8d5e2-a974-64ed-e053-2a95a90a83402024-09-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907
HydrochlorothiazideHYDROCHLOROTHIAZIDEProficient Rx LPff448eb4-b48f-46f5-ac30-f03aad08f9f52024-03-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040907
application number: ANDA040907

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-789-307093407893030 TABLET in 1 BOTTLE, PLASTIC (70934-789-30) 30 tablet2020-08-180000-00-00NoNoCurrent