Spironolactone
Spironolactone tablets, USP
Approved
Approval ID
4d2a314f-1573-4dab-82cc-e940e7ccb95e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2023
Manufacturers
FDA
NCS HealthCare of KY, LLC dba Vangard Labs
DUNS: 050052943
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
spironolactone
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0615-8178
Application NumberANDA203512
Product Classification
M
Marketing Category
C73584
G
Generic Name
spironolactone
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 25, 2023
FDA Product Classification
INGREDIENTS (13)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SPIRONOLACTONEActive
Quantity: 25 mg in 1 1
Code: 27O7W4T232
Classification: ACTIB
POVIDONE K25Inactive
Code: K0KQV10C35
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
PEPPERMINT OILInactive
Code: AV092KU4JH
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT