FDA.reportPublic FDA data

Hydrochlorothiazide

Product NDC
63739-128
Requested package NDC
63739-128-10
11-digit product format
637390128
Labeler code
63739
Product ID
63739-128_b3d6d2a8-97a2-5bad-e053-2a95a90a155d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Hydrochlorothiazide
Dosage form
TABLET
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA040412
Marketing category
ANDA
Marketing start
2002-03-29
Marketing end
2021-05-31
Substance
HYDROCHLOROTHIAZIDE
Active strength
25 mg/1
Pharmacologic classes
Increased Diuresis [PE],Thiazide Diuretic [EPC],Thiazides [CS]
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage63739-12863739-128-10DDiscontinued 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 · 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-128-102020-07-22C16284748780-1ab0e2407-358a-f274-e053-dbdaa90a6471HYDROCHLOROTHIAZIDE TABLETS, USP 25 mg and 50 mg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-128-10EA - Each63739-128001bdba0-8b72-4c2b-a012-3461faeaa64612013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrochlorothiazideACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [CARDINAL HEALTH]3
hydrochlorothiazideACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [CARDINAL HEALTH]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCHLOROTHIAZIDE TABLET [CARDINAL HEALTH]3
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [CARDINAL HEALTH]3
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [CARDINAL HEALTH]3
magnesium stearateINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [CARDINAL HEALTH]3
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THHYDROCHLOROTHIAZIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UHYDROCHLOROTHIAZIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8HYDROCHLOROTHIAZIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XHYDROCHLOROTHIAZIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30HYDROCHLOROTHIAZIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJHYDROCHLOROTHIAZIDE TABLET [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-128-106373901281010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-128-10) > 10 TABLET in 1 BLISTER PACK10 blister pack2002-03-292021-05-31NoNoCurrent