FDA.reportPublic FDA data

Hydrochlorothiazide

Product NDC
71610-323
Requested package NDC
71610-323-60
11-digit product format
716100323
Labeler code
71610
Product ID
71610-323_ef422f05-e092-41df-90b0-ada79fd4f0e3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA040907
Marketing category
ANDA
Marketing start
2009-07-02
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
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71610-32371610-323-60IInactivated by FDA2026-07-31

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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A040907-001HYDROCHLOROTHIAZIDE25MGTABLET / ORALAB2008-08-15a50c72e98297…
2026-08-01 22:54:322026-06A040907-002HYDROCHLOROTHIAZIDE50MGTABLET / ORALAB2008-08-15a50c72e98297…
2026-08-01 22:54:322026-06A040907-003HYDROCHLOROTHIAZIDE12.5MGTABLET / ORALAB2025-04-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A040907-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A040907-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A040907-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c19ec24d-2c40-4b8d-7c20-500ffa3660a1Product name320260303
1199f4b7-b537-466c-9a1c-cb09131e9f8bProduct name120251117
e1a63b6e-1877-c2c1-01a3-03ea2817aa6fProduct name320251027
b15e9aa6-d523-ca97-480e-570e0543a342Product name420251024
96816964-c075-ffa7-b7b8-d8570411a3b9Product name720250305
162cbc9d-ecc3-72ba-af9f-c76e2756ef54Product name320221207
9b303cd4-3186-2454-5706-3137e8b2dfd2Product name420221110
47fc2fe9-7afb-4be9-989d-787aaa6ad0eaProduct name120200505
a8e65197-7914-7acf-c7ec-914d53819b34Product name320190624
8b67f333-47d1-8464-7ce4-406d3dbb295fProduct name720190618
89a57420-ab44-5323-14f9-595159145f9bProduct name220190612
c27b049d-3258-48cf-ebe5-08c236ae78e2Product name320190610
00fc2cf9-672f-3e0b-6afa-43cbc864d058Product name420180613
15b375b1-89c7-9594-80df-5a8c8864aee0Product name320180108
a7349398-661d-d9fc-46df-7e128bbd61d9Product name520171113
1bdb87cf-9b1f-6a51-5eb7-d182aaffaa3dProduct name220170719
e0eeb018-194e-4b70-a57d-bac47a97b8eaProduct name120160825
55bffd21-17e1-ff02-2e8f-1f9a532b9502Product name220150320
ea069444-e874-4c28-833f-d2f52734ef4dProduct name120150206
041df61b-f8b6-48a6-7b67-411e1412678bProduct name120140508
0ad8bdca-888e-00da-648b-6a4de854a167Product name120140508
433a3439-b8f3-d13a-d2c8-9b221d628d60Product name120140508
59212689-39e5-a976-6d21-882d76d8079aProduct name120140508
7613b1a5-acb6-4e5e-6048-c44deeeb1212Product name120140508
78637fb0-95c8-441f-e4b4-db1274b6f956Product name120140508
df89bd47-2db4-d593-ab37-d11953fd5536Product name120140508
f151007d-265d-9fbe-857d-1d44f1cb76baProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71610-323-452023-01-30C16284748780-1f386c649-a5ac-0266-e053-dadaa90a7c1aHydrochlorothiazide Tablets, USP
71610-323-602023-01-30C16284748780-1f386c649-a5ac-0266-e053-dadaa90a7c1aHydrochlorothiazide Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-323-45Hydrochlorothiazide45 in 1 BOTTLETABLET451
71610-323-60Hydrochlorothiazide90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-323-45EA - Each71610-323d4912d1a-ba41-4453-ba5c-78df6af2cb0b12019-10-07
71610-323-60EA - Each71610-323e41203fc-93a9-4b30-8dee-fd2719a687d712019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-323HYDROCHLOROTHIAZIDE TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 2 package rows20190831_f21e4f2f-410c-44e8-8669-81f5e4200cb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197770hydroCHLOROthiazide 50 MG Oral TabletPSNf21e4f2f-410c-44e8-8669-81f5e4200cb91
197770hydrochlorothiazide 50 MG Oral TabletSCDf21e4f2f-410c-44e8-8669-81f5e4200cb91
197770HCTZ 50 MG Oral TabletSYf21e4f2f-410c-44e8-8669-81f5e4200cb91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-323-607161003236090 TABLET in 1 BOTTLE (71610-323-60) 90 tablet2019-08-130000-00-00NoNoCurrent