SILDENAFIL (Page 2 of 2)

Sildenafil 100mg Tablet

1216 label
(click image for full-size original)

Sildenafil 50mg Tablet

1218 label
(click image for full-size original)

SILDENAFIL sildenafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76519-1218
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILDENAFIL CITRATE (SILDENAFIL) SILDENAFIL 50 mg
Product Characteristics
Color white Score no score
Shape ROUND Size 11mm
Flavor Imprint Code I;36
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76519-1218-1 10 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:76519-1218-3 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202659 12/18/2018
SILDENAFIL sildenafil tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:76519-1216
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SILDENAFIL CITRATE (SILDENAFIL) SILDENAFIL 100 mg
Product Characteristics
Color white Score no score
Shape ROUND Size 14mm
Flavor Imprint Code I;58
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:76519-1216-1 10 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:76519-1216-5 15 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:76519-1216-3 30 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA202659 12/18/2018
Labeler — H.J. Harkins Company, Inc. (147681894)
Establishment
Name Address ID/FEI Operations
H.J. Harkins Company, Inc. 147681894 manufacture (76519-1216), relabel (76519-1216), repack (76519-1216), manufacture (76519-1218), relabel (76519-1218), repack (76519-1218)

Revised: 12/2018 H.J. Harkins Company, Inc.

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