FDA.reportPublic FDA data

Hydrochlorothiazide

Product NDC
70934-321
Requested package NDC
70934-321-90
11-digit product format
709340321
Labeler code
70934
Product ID
70934-321_a7200ccb-626f-4964-e053-2995a90ab968
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA078164
Marketing category
ANDA
Marketing start
2019-03-21
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
2021-12-31
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 packagepackage70934-32170934-321-90DDiscontinued 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
70934-321-302023-01-24C16284748780-1d6a99b39-ddfe-a426-e053-dadaa90af4c2Hydrochlorothiazide Capsules USP Rx only
70934-321-902023-01-24C16284748780-1d6a99b39-ddfe-a426-e053-dadaa90af4c2Hydrochlorothiazide Capsules USP Rx only
70934-321-302022-01-28C16284748780-1d6a99b39-ddfe-a426-e053-dadaa90af4c2Hydrochlorothiazide Capsules USP Rx only
70934-321-902022-01-28C16284748780-1d6a99b39-ddfe-a426-e053-dadaa90af4c2Hydrochlorothiazide Capsules USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70934-321-30EA - Each70934-32197133a09-95d6-49f2-890f-259ef0cd74c212022-12-07
70934-321-90EA - Each70934-321713ccd9b-60ce-494d-aa9e-1db0b2f3935112022-12-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-321-907093403219090 CAPSULE in 1 BOTTLE, PLASTIC (70934-321-90) 90 capsule2020-05-260000-00-00NoNoCurrent