FDA.reportPublic FDA data

Hydrochlorothiazide

Product NDC
50090-5672
Requested package NDC
50090-5672-2
11-digit product format
500905672
Labeler code
50090
Product ID
50090-5672_709be325-c07e-4041-a44c-65a094a50bf8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078164
Marketing category
ANDA
Marketing start
2007-09-19
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#

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 packagepackage50090-567250090-5672-2DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078164-001HYDROCHLOROTHIAZIDEHYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A078164-001AB

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 22:54:322026-06A078164-001HYDROCHLOROTHIAZIDE12.5MGCAPSULE / ORALAB2007-09-18a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078164-001AB1a50c72e98297…

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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HydrochlorothiazideHYDROCHLOROTHIAZIDEPreferred Pharmaceuticals Inc.82ad0fdf-5d47-4c2d-883b-f28b2d3fb6b02025-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078164
application number: ANDA078164
HydrochlorothiazideHYDROCHLOROTHIAZIDEBryant Ranch Prepack8242c1de-f482-4a85-b977-610e71fa49042024-10-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078164
application number: ANDA078164
HydrochlorothiazideHYDROCHLOROTHIAZIDERising Pharma Holdings, Inc.33f9c3ae-108d-469e-af6c-8be3b0f831392024-09-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078164
application number: ANDA078164
HydrochlorothiazideHYDROCHLOROTHIAZIDEAurobindo Pharma Limitede31bd548-29ae-419a-831a-80ebb26e042f2024-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078164
application number: ANDA078164

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5672-02023-02-07C16284748780-1f386c64a-49d2-0266-e053-dadaa90a7c1aHydrochlorothiazide Capsules USP Rx only
50090-5672-12023-02-07C16284748780-1f386c64a-49d2-0266-e053-dadaa90a7c1aHydrochlorothiazide Capsules USP Rx only
50090-5672-22023-02-07C16284748780-1f386c64a-49d2-0266-e053-dadaa90a7c1aHydrochlorothiazide Capsules USP Rx only
50090-5672-32023-02-07C16284748780-1f386c64a-49d2-0266-e053-dadaa90a7c1aHydrochlorothiazide Capsules USP Rx only
50090-5672-02023-01-30C16284748780-1f386c64a-49d2-0266-e053-dadaa90a7c1aHydrochlorothiazide Capsules USP Rx only
50090-5672-12023-01-30C16284748780-1f386c64a-49d2-0266-e053-dadaa90a7c1aHydrochlorothiazide Capsules USP Rx only
50090-5672-22023-01-30C16284748780-1f386c64a-49d2-0266-e053-dadaa90a7c1aHydrochlorothiazide Capsules USP Rx only
50090-5672-32023-01-30C16284748780-1f386c64a-49d2-0266-e053-dadaa90a7c1aHydrochlorothiazide Capsules USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5672-0EA - Each50090-5672c87b5785-a154-4eba-9c9b-e1b38c02007912022-10-06
50090-5672-1EA - Each50090-56726301219b-1680-4daf-83ca-cbb53ba0d45812022-10-06
50090-5672-2EA - Each50090-5672d2eb8e0c-6753-4dbf-b5eb-84252989351312022-10-06
50090-5672-3EA - Each50090-56724bd1e052-248a-4ee4-b765-2ce123c38d4212022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5672HYDROCHLOROTHIAZIDE CAPSULE [A-S MEDICATION SOLUTIONS]5Legacy NDC20231210_950da977-044b-434e-bc99-ed64d196fd4c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5672-25009056720260 CAPSULE in 1 BOTTLE (50090-5672-2) 60 capsule2021-09-160000-00-00NoNoCurrent