FDA.reportPublic FDA data

NDC 16729-225-19 - 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
16729-225
Requested NDC
16729-225-19
Package NDCs from labels
16729-225-01, 16729-225-16, 16729-225-17, 16729-225-19
Manufacturer
PD-Rx Pharmaceuticals, Inc.
Effective date
2026-05-21
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Spironolactone - PD-Rx Pharmaceuticals, Inc.PD-Rx Pharmaceuticals, Inc.2026-05-21HUMAN PRESCRIPTION DRUG LABEL
Spironolactone - Bryant Ranch PrepackBryant Ranch Prepack2026-05-14HUMAN PRESCRIPTION DRUG LABEL
Spironolactone - Accord Healthcare, Inc. | Intas Pharmaceuticals LimitedAccord Healthcare, Inc. | Intas Pharmaceuticals Limited2025-12-01HUMAN PRESCRIPTION DRUG LABEL
Spironolactone - REMEDYREPACK INC.REMEDYREPACK INC.2025-06-11HUMAN PRESCRIPTION DRUG LABEL
Spironolactone - Coupler LLCCoupler LLC2024-11-08HUMAN PRESCRIPTION DRUG LABEL
Spironolactone - Preferred Pharmaceuticals Inc..Preferred Pharmaceuticals Inc..2024-08-12HUMAN PRESCRIPTION DRUG LABEL
Spironolactone tablets, USPNuCare Pharmaceuticals, Inc. | NuCare Pharmaceutical, Inc.2024-07-10HUMAN PRESCRIPTION DRUG LABEL
Spironolactone - REMEDYREPACK INC.REMEDYREPACK INC.2024-02-29HUMAN PRESCRIPTION DRUG LABEL
Spironolactone - Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEMAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2023-10-03HUMAN PRESCRIPTION DRUG LABEL
Spironolactone - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2023-06-07HUMAN PRESCRIPTION DRUG LABEL
Spironolactone - Proficient Rx LPProficient Rx LP2023-04-01HUMAN PRESCRIPTION DRUG LABEL
Spironolactone - A-S Medication SolutionsA-S Medication Solutions2023-02-06HUMAN PRESCRIPTION DRUG LABEL
Spironolactone - NCS HealthCare of KY, LLC dba Vangard LabsNCS HealthCare of KY, LLC dba Vangard Labs2023-01-25HUMAN PRESCRIPTION DRUG LABEL
Spironolactone - Direct_RxDirect_Rx2022-10-11HUMAN PRESCRIPTION DRUG LABEL
Spironolactone - Quality Care Products, LLCQuality Care Products, LLC2022-08-18HUMAN PRESCRIPTION DRUG LABEL
Spironolactone - Denton Pharma, Inc. DBA Northwind PharmaceuticalsDenton Pharma, Inc. DBA Northwind Pharmaceuticals2020-06-02HUMAN PRESCRIPTION DRUG LABEL
Spironolactone - REMEDYREPACK INC.REMEDYREPACK INC.2020-05-11HUMAN PRESCRIPTION DRUG LABEL
Spironolactone - Bryant Ranch PrepackBryant Ranch Prepack2019-08-07HUMAN PRESCRIPTION DRUG LABEL
POVIDONE K25 - St. Mary's Medical Park Pharmacy | Intas Pharmaceuticals LimitedSt. Mary's Medical Park Pharmacy | Intas Pharmaceuticals Limited2018-11-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-225-01Spironolactone100 in 1 BOTTLETABLET, FILM COATED10011
16729-225-16Spironolactone500 in 1 BOTTLETABLET, FILM COATED50011
16729-225-17Spironolactone1000 in 1 BOTTLETABLET, FILM COATED100011
16729-225-19Spironolactone2500 in 1 BOTTLETABLET, FILM COATED250011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-225SPIRONOLACTONE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.]10Current NDC, Legacy NDC, 4 package rows20240216_8a96e2c9-049a-43ab-abf3-21baedeb736f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-225-01EA - Each16729-2255df07980-5905-4ae5-831d-2392fd34b6eb12017-06-15
16729-225-16EA - Each16729-2259939c8c7-431f-4014-9577-356596f54dc812017-06-15
16729-225-17EA - Each16729-225b9922f80-2363-4ac9-b8a6-b502aefe5bb612017-07-07

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 2 of 146 · 2,908 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPIRONOLACTONESPIRONOLACTONEPreferred Pharmaceuticals Inc.3486d831-06b6-4e8f-bd6f-52f7759988f52026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 198222
unii: 27O7W4T232
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
SPIRONOLACTONESPIRONOLACTONEATLANTIC BIOLOGICALS CORP.122558a0-57bb-4195-9adf-d37b049cbfb52026-08-26Warnings, Adverse reactionsExact identifier
unii: 27O7W4T232
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
SPIRONOLACTONESPIRONOLACTONERedpharm Drug59d86d3a-0f94-0b04-e063-6294a90a83f32026-08-25Warnings, Adverse reactionsExact identifier
rxcui: 313096
unii: 27O7W4T232
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
SpironolactoneSPIRONOLACTONECardinal Health 107, LLC48115c9e-c82f-438d-b178-dce1b73687db2026-08-25Warnings, Adverse reactionsExact identifier
rxcui: 313096
unii: 27O7W4T232
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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