Cialis
These highlights do not include all the information needed to use CIALIS safely and effectively. See full prescribing information for CIALIS. CIALIS (tadalafil) tablets, for oral use Initial U.S. Approval: 2003
Approved
Approval ID
0e747223-2740-4e45-9bef-ae5f7798064a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 15, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 3
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 Code54868-4665
Application NumberNDA021368
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tadalafil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2011
FDA Product Classification
INGREDIENTS (12)
Lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
TriacetinInactive
Code: XHX3C3X673
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TadalafilActive
Quantity: 10 mg in 1 1
Code: 742SXX0ICT
Classification: ACTIM
Hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
Sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
Cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
Tadalafil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-5956
Application NumberNDA021368
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tadalafil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2011
FDA Product Classification
INGREDIENTS (12)
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
Lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
TriacetinInactive
Code: XHX3C3X673
Classification: IACT
TadalafilActive
Quantity: 5 mg in 1 1
Code: 742SXX0ICT
Classification: ACTIM
Hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
Sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Tadalafil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54868-4968
Application NumberNDA021368
Product Classification
M
Marketing Category
C73594
G
Generic Name
Tadalafil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 15, 2011
FDA Product Classification
INGREDIENTS (12)
TadalafilActive
Quantity: 20 mg in 1 1
Code: 742SXX0ICT
Classification: ACTIM
Hydroxypropyl celluloseInactive
Code: RFW2ET671P
Classification: IACT
HypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
Lactose monohydrateInactive
Code: EWQ57Q8I5X
Classification: IACT
TriacetinInactive
Code: XHX3C3X673
Classification: IACT
Magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
Sodium lauryl sulfateInactive
Code: 368GB5141J
Classification: IACT
Cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT
TalcInactive
Code: 7SEV7J4R1U
Classification: IACT
Titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
Croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT