FDA.reportPublic FDA data

NDC 50090-0136-01 - 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
50090-0136
Requested NDC
50090-0136-01
Package NDCs from labels
50090-0136-6, 50090-0136-0, 50090-0136-1, 50090-0136-3, 50090-0136-01
Manufacturer
A-S Medication Solutions
Effective date
2023-04-07
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SPIRONOLACTONE - A-S Medication SolutionsA-S Medication Solutions2023-04-07HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0136-0SPIRONOLACTONE100 in 1 BOTTLE, PLASTICTABLET10011
50090-0136-1SPIRONOLACTONE30 in 1 BOTTLE, PLASTICTABLET3011
50090-0136-3SPIRONOLACTONE60 in 1 BOTTLE, PLASTICTABLET6011
50090-0136-6SPIRONOLACTONE90 in 1 BOTTLE, PLASTICTABLET9011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0136SPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 4 package rows20230414_200b2a6a-f263-463e-a2e1-f4f74058a924.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0136-0EA - Each50090-01360afab01a-9419-4cbe-9e14-882b6b967ced12018-08-13
50090-0136-1EA - Each50090-01361267b118-e8db-478a-ba3f-3392adecf65f12018-08-13
50090-0136-6EA - Each50090-013632cb1ede-cbda-4daa-9922-83cae6aca39812018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SpironolactoneACTIVE INGREDIENT27O7W4T232SPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1
SpironolactoneACTIVE MOIETY27O7W4T232SPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKSPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61USPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1
crospovidoneINACTIVE INGREDIENT68401960MKSPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1
docusate sodiumINACTIVE INGREDIENTF05Q2T2JA0SPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4SPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1
sodium benzoateINACTIVE INGREDIENTOJ245FE5EUSPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1
sodium starch glycolate type a potatoINACTIVE INGREDIENT5856J3G2A2SPIRONOLACTONE TABLET [A-S MEDICATION SOLUTIONS LLC]1

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 4 of 57 · 1,133 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thyro-ChordHOMEOPATHIC LIQUIDEnergetix Corporation6655b504-dfa8-46df-9d3a-b7fa4078207e2026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Para-ChordHOMEOPATHIC LIQUIDEnergetix Corporation9f8f646e-634a-47ff-b208-b2249d685e552026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
MycoCan-ChordALUMINA, AVENA SATIVA, BORAX, CANDIDA ALBICANS, CARBOLICUM ACIDUM, CEANOTHUS AMERICANUS, ECHINACEA, GAULTHERIA PROCUMBENS, GLANDULA SUPRARENALIS SUIS, HYDRASTIS CANADENSIS, LINUM USITATISSIMUM, LITHIUM CARBONICUM, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, PHYTOLACCA DECANDRA, SARCOLACTICUM ACIDUM, SEPIA, SILICEA, SOLIDAGO VIRGAUREA, TELLURIUM METALLICUM, TEUCRIUM MARUM, ZINCUM METALLICUMEnergetix Corporation227199f8-a45e-44ff-892d-ade4fefea3542026-08-11WarningsExact identifier
unii: ETJ7Z6XBU4
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f4671579-aed0-4f93-ab83-248e0d72b5b02026-08-10WarningsExact identifier
unii: F05Q2T2JA0
Docusate Sodium LiquidDOCUSATE SODIUM.50MG/5MLAldama Pharmaceuticals, Inc492b6d37-47cf-3a28-e063-6294a90a2a182026-08-10WarningsExact identifier
unii: F05Q2T2JA0
SpironolactoneSPIRONOLACTONEPD-Rx Pharmaceuticals, Inc.c0efa529-2870-4260-b604-2f30e2cbb87b2026-08-07Warnings, Adverse reactionsExact identifier
rxcui: 198222
unii: 27O7W4T232
Senna SDOCUSATE SODIUM, SENNOSIDESShield Pharmaceuticals Corp0be906d8-3db5-4218-bbdf-f1d1260079902026-08-07WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener Extra StrengthDOCUSATE SODIUMP & L Development, LLC4e97dd60-96e3-4b51-b614-c62480af19192026-08-06WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLC098d2377-0019-45fe-b995-700b1b1241c42026-08-05WarningsExact identifier
unii: F05Q2T2JA0
Docusate Sodium softgels 50mg (Dye Free)DOCUSATE SODIUMCVS Pharmacy273ea95f-3c9c-98e8-e063-6294a90a21352026-08-05WarningsExact identifier
unii: F05Q2T2JA0
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcbb0edf4-1fa7-42f5-a6f7-027e3961b50a2026-08-05WarningsExact identifier
unii: F05Q2T2JA0
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.7793fced-e8ee-44e2-b212-dd2a59a5f4622026-08-04WarningsExact identifier
unii: F05Q2T2JA0
Dual Action Senna Stool SoftenerDOCUSATE SODIUM 50 MG, SENNOSIDES 8.6 MGShield Pharmaceuticals Corpa04435df-aace-497f-a3a8-d8e8489db6612026-08-03WarningsExact identifier
unii: F05Q2T2JA0
SPIRONOLACTONESPIRONOLACTONESun Pharmaceutical Industries, Inc.c23b6b9b-aec3-48a8-a518-76e4097f64792026-07-31Warnings, Adverse reactionsExact identifier
application number: ANDA089424
ndc (product): 53489-143
rxcui: 198222
rxcui: 313096
rxcui: 198223
spl id: 57e3eb73-8cac-c76d-e063-6394a90a5962
spl set id: c23b6b9b-aec3-48a8-a518-76e4097f6479
unii: 27O7W4T232
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
SPIRONOLACTONESPIRONOLACTONERedpharm Drug57d1c333-c229-54aa-e063-6394a90a84ce2026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 198223
unii: 27O7W4T232
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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