FDA.reportPublic FDA data

Spironolactone and Hydrochlorothiazide

Product NDC
59762-5014
11-digit product format
597625014
Labeler code
59762
Product ID
59762-5014_84a7e143-8b37-4adc-a07b-2da581124df5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
spironolactone and hydrochlorothiazide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Greenstone LLC
Application
NDA012616
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1978-01-01
Marketing end
0000-00-00
Substance
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
Active strength
25 mg/1; mg/1
Pharmacologic classes
Aldosterone Antagonist [EPC], Aldosterone Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]
NDC exclude flag
No
Listing certified through
2024-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59762-5014DDiscontinued by firm2026-07-31
excluded packagepackage59762-501459762-5014-1DDiscontinued 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
N012616-004ALDACTAZIDEHYDROCHLOROTHIAZIDE; SPIRONOLACTONE25MG;25MGTABLET / ORALABRLD1982-12-30
N012616-005ALDACTAZIDEHYDROCHLOROTHIAZIDE; SPIRONOLACTONE50MG;50MGTABLET / ORALRLD1982-12-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N012616-004AB

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 22:54:322026-06N012616-004ALDACTAZIDE25MG;25MGTABLET / ORALABRLD1982-12-30a50c72e98297…
2026-08-01 22:54:322026-06N012616-005ALDACTAZIDE50MG;50MGTABLET / ORALRLD1982-12-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N012616-004AB1a50c72e98297…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Spironolactone and HydrochlorothiazideSPIRONOLACTONE AND HYDROCHLOROTHIAZIDEPrasco Laboratories9d350fa2-d568-4970-a7a5-d128ff5d0a2f2026-02-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 012616
application number: NDA012616

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-5014-1EA - Each59762-5014aa1d8675-ba01-4475-b655-c164ad2005be12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCHLOROTHIAZIDEACTIVE INGREDIENT0J48LPH2THSPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [GREENSTONE LLC]7
SPIRONOLACTONEACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [GREENSTONE LLC]7
HYDROCHLOROTHIAZIDEACTIVE MOIETY0J48LPH2THSPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [GREENSTONE LLC]7
SPIRONOLACTONEACTIVE MOIETY27O7W4T232SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [GREENSTONE LLC]7
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [GREENSTONE LLC]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [GREENSTONE LLC]7
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PSPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [GREENSTONE LLC]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [GREENSTONE LLC]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [GREENSTONE LLC]7
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [GREENSTONE LLC]7
POVIDONESINACTIVE INGREDIENTFZ989GH94ESPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [GREENSTONE LLC]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJSPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [GREENSTONE LLC]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSPIRONOLACTONE AND HYDROCHLOROTHIAZIDE TABLET, FILM COATED [GREENSTONE LLC]7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-5014-159762501401100 TABLET, FILM COATED in 1 BOTTLE (59762-5014-1) 1978-01-010000-00-00NoNoCurrent