MedPath

Viagra

Viagra

Approved
Approval ID

4d60822d-1c9b-494d-adb3-20fe921d9c58

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 22, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

sildenafil citrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-157
Application NumberNDA020895
Product Classification
M
Marketing Category
C73594
G
Generic Name
sildenafil citrate
Product Specifications
Route of AdministrationORAL
Effective DateJune 21, 2010
FDA Product Classification

INGREDIENTS (11)

SILDENAFIL CITRATEActive
Quantity: 50 mg in 1 1
Code: BW9B0ZE037
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT

sildenafil citrate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-158
Application NumberNDA020895
Product Classification
M
Marketing Category
C73594
G
Generic Name
sildenafil citrate
Product Specifications
Route of AdministrationORAL
Effective DateJune 21, 2010
FDA Product Classification

INGREDIENTS (11)

CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SILDENAFIL CITRATEActive
Quantity: 100 mg in 1 1
Code: BW9B0ZE037
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
LACTOSEInactive
Code: J2B2A4N98G
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT

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