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 1 of 149 · 2,980 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
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
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
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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