FDA.reportPublic FDA data

Hydrochlorothiazide

Product NDC
50090-2213
11-digit product format
500902213
Labeler code
50090
Product ID
50090-2213_02c81810-f1d6-4323-bba7-e31a56e07601
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040412
Marketing category
ANDA
Marketing start
2002-03-29
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
2019-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct50090-2213IInactivated by FDA2026-07-31
excluded packagepackage50090-221350090-2213-0IInactivated by FDA2026-07-31
excluded packagepackage50090-221350090-2213-1IInactivated by FDA2026-07-31
excluded packagepackage50090-221350090-2213-8IInactivated 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040412-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29
A040412-002HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29

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 22:54:322026-06A040412-001HYDROCHLOROTHIAZIDE25MGTABLET / ORAL2002-03-29a50c72e98297…
2026-08-01 22:54:322026-06A040412-002HYDROCHLOROTHIAZIDE50MGTABLET / ORAL2002-03-29a50c72e98297…

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 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEAmerican Health Packagingc8de63da-b6c0-42f0-9d47-e273fe93adb32026-04-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack5f2e72cc-073d-4bb5-95fe-53d4060127ec2024-12-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack78d65a02-c78e-4f98-b756-3cb5ee78f2522024-02-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack24cba606-263f-46dc-a4dc-fddc729c0f4b2023-10-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack4c3403a6-da6a-4f37-bc7e-9fe0aa2843052021-12-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack0fdb6713-8013-4cfe-a776-0c1e9414a91c2020-06-02Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412
HydrochlorothiazideHYDROCHLOROTHIAZIDESolco Healthcare U.S., LLC60c97ab9-b25e-4ea5-a159-792292178c652020-05-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040412
application number: ANDA040412

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
50090-2213-02020-01-31C16284748780-19d75b9d1-1851-f424-e053-dadaa90a57ceHYDROCHLOROTHIAZIDE TABLETS, USP 25 mg and 50 mg
50090-2213-12020-01-31C16284748780-19d75b9d1-1851-f424-e053-dadaa90a57ceHYDROCHLOROTHIAZIDE TABLETS, USP 25 mg and 50 mg
50090-2213-82020-01-31C16284748780-19d75b9d1-1851-f424-e053-dadaa90a57ceHYDROCHLOROTHIAZIDE TABLETS, USP 25 mg and 50 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2213-0Hydrochlorothiazide30 in 1 BOTTLETABLET303
50090-2213-1Hydrochlorothiazide100 in 1 BOTTLETABLET1003
50090-2213-8Hydrochlorothiazide200 in 1 BOTTLETABLET2003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2213HYDROCHLOROTHIAZIDE TABLET [A-S MEDICATION SOLUTIONS]3Legacy NDC, 3 package rows20180131_5e31ad37-88d9-4bae-919d-92869ae0b088.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310798hydroCHLOROthiazide 25 MG Oral TabletPSN5e31ad37-88d9-4bae-919d-92869ae0b0883
310798hydrochlorothiazide 25 MG Oral TabletSCD5e31ad37-88d9-4bae-919d-92869ae0b0883
310798HCTZ 25 MG Oral TabletSY5e31ad37-88d9-4bae-919d-92869ae0b0883

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-2213-05009022130030 in 1 BOTTLEHistorical
50090-2213-150090221301100 in 1 BOTTLEHistorical
50090-2213-850090221308200 in 1 BOTTLEHistorical