FDA.reportPublic FDA data

Hydrochlorothiazide

Product NDC
68788-7475
Requested package NDC
68788-7475-6
11-digit product format
687887475
Labeler code
68788
Product ID
68788-7475_8dc0c76e-bafa-456e-83d1-e99f21adb4df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078164
Marketing category
ANDA
Marketing start
2020-02-28
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 packagepackage68788-747568788-7475-6DDiscontinued 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7475-1EA - Each68788-747549e1cea8-09ce-4c78-a7ea-c9ff56bb418b12020-04-20
68788-7475-3EA - Each68788-74754b90e0c4-c6e5-437b-a1d8-8b880172d6db12020-04-20
68788-7475-6EA - Each68788-747586e9793d-90db-4c07-9605-4ab129c0169412020-04-20
68788-7475-7EA - Each68788-747505756cc2-7ba1-40d1-ad76-024430102c3512020-04-20
68788-7475-9EA - Each68788-74755aa50f2d-061b-4e46-99c8-e6d0c004fbb712020-04-20

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7475-66878874750660 CAPSULE in 1 BOTTLE (68788-7475-6) 60 capsule2020-02-280000-00-00NoNoCurrent