FDA.reportPublic FDA data

NDC 71335-0053-08 - Spironolactone

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
71335-0053
Requested NDC
71335-0053-08
Package NDCs from labels
71335-0053-1, 71335-0053-2, 71335-0053-3, 71335-0053-4, 71335-0053-5, 71335-0053-6, 71335-0053-7, 71335-0053-8, 71335-0053-9, 71335-0053-08
Manufacturer
Bryant Ranch Prepack
Effective date
2026-05-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Spironolactone - Bryant Ranch PrepackBryant Ranch Prepack2026-05-14HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71335-0053-12024-05-17These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
71335-0053-22024-05-17These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
71335-0053-32024-05-17These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
71335-0053-42024-05-17These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
71335-0053-52024-05-17These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
71335-0053-62024-05-17These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
71335-0053-72024-05-17These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
71335-0053-12024-01-30These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
71335-0053-22024-01-30These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
71335-0053-32024-01-30These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
71335-0053-42024-01-30These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
71335-0053-52024-01-30These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
71335-0053-62024-01-30These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960
71335-0053-72024-01-30These highlights do not include all the information needed to use SPIRONOLACTONE TABLETS safely and effectively. See full prescribing information for SPIRONOLACTONE TABLETS. SPIRONOLACTONE tablets for oral use Initial U.S. Approval: 1960

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0053-1Spironolactone30 in 1 BOTTLETABLET, FILM COATED3018
71335-0053-2Spironolactone60 in 1 BOTTLETABLET, FILM COATED6018
71335-0053-3Spironolactone90 in 1 BOTTLETABLET, FILM COATED9018
71335-0053-4Spironolactone14 in 1 BOTTLETABLET, FILM COATED1418
71335-0053-5Spironolactone100 in 1 BOTTLETABLET, FILM COATED10018
71335-0053-6Spironolactone7 in 1 BOTTLETABLET, FILM COATED718
71335-0053-7Spironolactone10 in 1 BOTTLETABLET, FILM COATED1018
71335-0053-8Spironolactone180 in 1 BOTTLETABLET, FILM COATED18018
71335-0053-9Spironolactone45 in 1 BOTTLETABLET, FILM COATED4518

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0053SPIRONOLACTONE TABLET, FILM COATED [BRYANT RANCH PREPACK]17Current NDC, Legacy NDC, 9 package rows20240518_650bf1c1-b7f1-4e5b-a9f0-3a2e31b98dd3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0053-1EA - Each71335-0053a19d83e6-5e71-4650-a604-fb7081f70b3712018-03-08
71335-0053-2EA - Each71335-00536b6fdb07-99a3-4045-9674-0378e05ac81b12018-03-08
71335-0053-3EA - Each71335-00539b0e8c61-9396-4407-b5ec-962808835f2612018-03-08
71335-0053-4EA - Each71335-005323acacac-b281-4fa0-8d01-0ffb261ac7f512018-03-08
71335-0053-5EA - Each71335-005318c6fed6-bde2-450a-9dfe-d36f272c430e12018-03-08

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 146 · 2,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
spironolactoneSPIRONOLACTONEREMEDYREPACK INC.8b76a904-6c99-485a-a05f-13a36c5f720c2026-09-15Warnings, Adverse reactionsExact identifier
rxcui: 198222
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack3b60de71-2afa-4922-ba3e-0664c2ae29a02026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 198223
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackd6138536-cdc1-4459-84ff-9dedc0de11052026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 313096
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackcaf41e17-0461-4667-9eab-62853b9451312026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 198223
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepacka6e0bf0e-42d3-41e4-854b-811df3bbaaa92026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 198223
unii: 27O7W4T232
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack1fe93db1-0012-4ff6-a4e6-04e2d7e9f6382026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 198222
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack1b29888c-09f9-4cd5-9b4c-920bd159a7272026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 313096
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepackb98b7780-e310-493a-83bd-bb3d93cf8dde2026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 313096
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack753bbc6f-2e50-49c1-b5bf-18f8411a1e8e2026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 313096
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEBryant Ranch Prepack0cc23419-e6d5-4036-8011-dc1d2455e0cb2026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 198222
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEREMEDYREPACK INC.7c59e03a-b058-4f6e-b104-0836d9b563922026-09-08Warnings, Adverse reactionsExact identifier
rxcui: 313096
unii: 27O7W4T232
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
Dr.Harry EYES PROTECTIONPOLYETHYLENE GLYCOL 400 1% EYES PROTECTIONWenzhou Yuyuan Pharmaceutical Co., Ltd.5a9fe033-89d3-da62-e063-6294a90a45032026-09-03WarningsExact identifier
unii: B697894SGQ
SpironolactoneSPIRONOLACTONEPreferred Pharmaceuticals Inc.5e456f3c-f93e-41c6-80c5-a737ed70feda2026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 198223
unii: 27O7W4T232
SpironolactoneSPIRONOLACTONEPreferred Pharmaceuticals Inc.4290b3ec-8993-47d4-bfe3-fcb81d7baed82026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 313096
unii: 27O7W4T232
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
SPIRONOLACTONESPIRONOLACTONEAtlantic Biologicals Corp.5a203ae4-0ed1-0099-e063-6294a90abc852026-08-28Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
SPIRONOLACTONESPIRONOLACTONEPreferred Pharmaceuticals Inc.3486d831-06b6-4e8f-bd6f-52f7759988f52026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 198222
unii: 27O7W4T232

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.