Tadalafil
These highlights do not include all the information needed to use TADALAFIL TABLETS safely and effectively. See full prescribing information for TADALAFIL TABLETS. TADALAFIL tablets, for oral administration Initial U.S. Approval: 2003
Approved
Approval ID
0afd0728-256a-293b-e063-6394a90a3c5f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2024
Manufacturers
FDA
Northwind Pharmaceuticals, LLC
DUNS: 036986393
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Tadalafil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code82868-028
Application NumberANDA206286
Product Classification
M
Marketing Category
C73584
G
Generic Name
Tadalafil
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 1, 2024
FDA Product Classification
INGREDIENTS (13)
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSE 102Inactive
Code: PNR0YF693Y
Classification: IACT
POLYOXYL 40 HYDROGENATED CASTOR OILInactive
Code: 7YC686GQ8F
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TADALAFILActive
Quantity: 20 mg in 1 1
Code: 742SXX0ICT
Classification: ACTIB