VYBRIQUE- sildenafil oral film film 
Altergon Italia SRL

----------

Vybrique

Vybrique is indicated for erectile dysfunction

Vybrique 25 mg 2 pack sample

NDC 43328-016-02

Vybrique 25mg

sildenafil oral film

2 pack sample

25 mg 2 pack

Vibrique 25 mg 4 pack

Vybrique

Sildeanfil Oral Film

4 pack

25 mg 4 pack

Vybrique 25 mg 8 pack

NDC 43328-016-08

Vybrique 25 mg

sildenafil oral film

8 pack

25 mg 8 pack

Vybrique 50 mg 2 pack sample

NDC 43328-017-02

Vybrique 50 mg

sildenafil oral film

2 pack sample

50 mg 2 pack

Vybrique 50 mg 4 pack

NDC 43328-017-04

Vybrique 50 mg

sildenafil oral film

4 pack

50 mg 4 pack

Vybrique 50 mg 8 pack

NDC 43328-017-08

Vybrique 50 mg

sildenafil oral film

8 pack

50 mg 8 pack

Vybrique 75 mg 2 pack sample

NDC 43328-018-02

Vybrique 75 mg

sildenafil oral film

2 pack sample

75 mg 2 pack

Vybrique 75 mg 4 pack

NDC 43328-018-04

Vybrique 75 mg

sildenafil oral film

4 pack

75 mg 4 pack

Vybrique 75 mg 8 pack

NDC 43328-018-08

Vybrique 75 mg

sildenafil oral film

8 pack

75 mg 8 pack

Vybrique 100 mg 2 pack sample

NDC 43328-019-02

Vybrique 100 mg

sildenafil oral film

2 pack sample

100 mg 2pack

Vybrique 100 mg 4 pack

NDC 43328-019-04

Vybrique 100 mg

sildenafil oral film

4 pack

100 mg 4 pack

Vybrique 100 mg 8 pack

NDC 43328-019-08

Vybrique 100 mg

sildenafil oral film

8 pack

100 mg 8 pack

VYBRIQUE 
sildenafil oral film film
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43328-016
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H) SILDENAFIL25 mg
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GLYCERIN (UNII: PDC6A3C0OX)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
PROPYLENE GLYCOL MONOCAPRYLATE (UNII: RT9P9S09QI)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON, GRAPEFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43328-016-044 in 1 CARTON02/15/2026
1NDC:43328-016-011 in 1 POUCH; Type 0: Not a Combination Product
2NDC:43328-016-088 in 1 CARTON02/15/2026
2NDC:43328-016-011 in 1 POUCH; Type 0: Not a Combination Product
3NDC:43328-016-022 in 1 CARTON02/15/2026
3NDC:43328-016-011 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21085802/15/2026
VYBRIQUE 
sildenafil oral film film
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43328-019
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H) SILDENAFIL100 mg
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
PROPYLENE GLYCOL MONOCAPRYLATE (UNII: RT9P9S09QI)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON, GRAPEFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43328-019-044 in 1 CARTON02/15/2026
1NDC:43328-019-011 in 1 POUCH; Type 0: Not a Combination Product
2NDC:43328-019-088 in 1 CARTON02/15/2026
2NDC:43328-019-011 in 1 POUCH; Type 0: Not a Combination Product
3NDC:43328-019-022 in 1 CARTON02/15/2026
3NDC:43328-019-011 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21085802/15/2026
VYBRIQUE 
sildenafil oral film film
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43328-018
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H) SILDENAFIL75 mg
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
PROPYLENE GLYCOL MONOCAPRYLATE (UNII: RT9P9S09QI)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON, GRAPEFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43328-018-044 in 1 CARTON02/15/2026
1NDC:43328-018-011 in 1 POUCH; Type 0: Not a Combination Product
2NDC:43328-018-088 in 1 CARTON02/15/2026
2NDC:43328-018-011 in 1 POUCH; Type 0: Not a Combination Product
3NDC:43328-018-022 in 1 CARTON02/15/2026
3NDC:43328-018-011 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA21085802/15/2026
VYBRIQUE 
sildenafil oral film film
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:43328-017
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SILDENAFIL CITRATE (UNII: BW9B0ZE037) (SILDENAFIL - UNII:3M7OB98Y7H) SILDENAFIL50 mg
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
GLYCERIN (UNII: PDC6A3C0OX)  
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
SUCRALOSE (UNII: 96K6UQ3ZD4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
PROPYLENE GLYCOL MONOCAPRYLATE (UNII: RT9P9S09QI)  
Product Characteristics
Color    Score    
ShapeSize
FlavorLEMON, GRAPEFRUITImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43328-017-044 in 1 CARTON02/15/2026
1NDC:43328-017-011 in 1 POUCH; Type 0: Not a Combination Product
2NDC:43328-017-088 in 1 CARTON02/15/2026
2NDC:43328-017-011 in 1 POUCH; Type 0: Not a Combination Product
3NDC:43328-017-022 in 1 CARTON02/15/2026
3NDC:43328-017-011 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)

Revised: 1/2026
Document Id: 4833eb62-25f7-d68d-e063-6294a90ab817
Set id: 4833eb62-25f6-d68d-e063-6294a90ab817
Version: 1
Effective Time: 20260126
 
Altergon Italia SRL