SILDENAFIL ORAL FILM ( s ildenafil ) oral film

Sildenafil by

Drug Labeling and Warnings

Sildenafil by is a Prescription medication manufactured, distributed, or labeled by Altergon Italia srl, IBSA Institut Biochimique SA. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SILDENAFIL- sildenafil citrate film 
Altergon Italia srl

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SILDENAFIL ORAL FILM(sildenafil)oral film

1.INDICATIONSAND USAGE

SILDENAFIL ORAL FILM is indicated for the treatment of erectile dysfunction.

PRINCIPAL DISPLAY PANEL

NDC: 43328-020-04
25 mg
Sildenafil oral film
25 mg per oral film

25 pack 4

PRINCIPAL DISPLAY PANEL

NDC: 43328-020-08
25 mg
Sildenafil oral film
25 mg per oral film

25 pack 8

PRINCIPAL DISPLAY PANEL

NDC: 43328-021-04
50 mg
Sildenafil oral film
50 mg per oral film

50 pack 4

PRINCIPAL DISPLAY PANEL

NDC: 43328-021-08
75 mg
Sildenafil oral film
75 mg per oral film

50 pack 8

PRINCIPAL DISPLAY PANEL

NDC: 43328-022-04
75 mg
Sildenafil oral film
75 mg per oral film

75 pack 4

PRINCIPAL DISPLAY PANEL

NDC: 43328-020-08
75 mg
Sildenafil oral film
75 mg per oral film

75 pack 8

PRINCIPAL DISPLAY PANEL

NDC: 43328-023-04
100 mg
Sildenafil oral film
100 mg per oral film

100 pack 4

PRINCIPAL DISPLAY PANEL

NDC: 43328-023-08
100 mg
Sildenafil oral film
100 mg per oral film

100 pack 8

SILDENAFIL 
sildenafil citrate film
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 43328-020
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H) SILDENAFIL25 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL MONOCAPRYLATE (UNII: RT9P9S09QI)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
Product Characteristics
Colorblue (opaque light blue) Score    
ShapeSize
FlavorLEMON, GRAPEFRUITImprint Code S25
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43328-020-011 in 1 POUCH; Type 0: Not a Combination Product02/15/2026
2NDC: 43328-020-044 in 1 CARTON02/15/2026
21 in 1 POUCH; Type 0: Not a Combination Product
3NDC: 43328-020-088 in 1 CARTON02/15/2026
31 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21085802/15/2026
SILDENAFIL 
sildenafil citrate film
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 43328-021
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H) SILDENAFIL50 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL MONOCAPRYLATE (UNII: RT9P9S09QI)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
Product Characteristics
Colorblue (opaque light blue) Score    
ShapeSize
FlavorLEMON, GRAPEFRUITImprint Code S50
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43328-021-011 in 1 POUCH; Type 0: Not a Combination Product02/15/2026
2NDC: 43328-021-044 in 1 CARTON02/15/2026
21 in 1 POUCH; Type 0: Not a Combination Product
3NDC: 43328-021-088 in 1 CARTON02/15/2026
31 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21085802/15/2026
SILDENAFIL 
sildenafil citrate film
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 43328-022
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H) SILDENAFIL75 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL MONOCAPRYLATE (UNII: RT9P9S09QI)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
Product Characteristics
Colorblue (opaque light blue) Score    
ShapeSize
FlavorLEMON, GRAPEFRUITImprint Code S75
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43328-022-011 in 1 POUCH; Type 0: Not a Combination Product02/15/2026
2NDC: 43328-022-044 in 1 CARTON02/15/2026
21 in 1 POUCH; Type 0: Not a Combination Product
3NDC: 43328-022-088 in 1 CARTON02/15/2026
31 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21085802/15/2026
SILDENAFIL 
sildenafil citrate film
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 43328-023
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H) SILDENAFIL100 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL MONOCAPRYLATE (UNII: RT9P9S09QI)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
Product Characteristics
Colorblue (opaque light blue) Score    
ShapeSize
FlavorLEMON, GRAPEFRUITImprint Code S100
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43328-023-011 in 1 POUCH; Type 0: Not a Combination Product02/15/2026
2NDC: 43328-023-044 in 1 CARTON02/15/2026
21 in 1 POUCH; Type 0: Not a Combination Product
3NDC: 43328-023-088 in 1 CARTON02/15/2026
31 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21085802/15/2026
Labeler - Altergon Italia srl (458276941)
Registrant - IBSA Institut Biochimique SA (480278696)

Revised: 2/2026
Document Id: 49eb78c3-9796-6708-e063-6294a90ad6e5
Set id: 49eb7ff2-142a-43e0-e063-6394a90a2054
Version: 1
Effective Time: 20260203
 
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