PREGABALIN (Page 11 of 11)

Package/Label Display Panel

Pregabalin Capsules CV

50 mg

10 Capsules

bag label
(click image for full-size original)

Package/Label Display Panel

Pregabalin Capsules CV

75 mg

10 Capsules

bag label
(click image for full-size original)
PREGABALIN pregabalin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-8097(NDC:0904-6992)
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN (PREGABALIN) PREGABALIN 50 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
TALC
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
SHELLAC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
Product Characteristics
Color WHITE (white opaque) Score no score
Shape CAPSULE (size “3″ hard gelatin capsule) Size 16mm
Flavor Imprint Code LA;42
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-8097-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 CAPSULE in 1 BLISTER PACK This package is contained within the BAG (55154-8097-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210432 07/19/2019
PREGABALIN pregabalin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55154-8098(NDC:0904-7000)
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN (PREGABALIN) PREGABALIN 75 mg
Inactive Ingredients
Ingredient Name Strength
STARCH, CORN
TALC
GELATIN, UNSPECIFIED
SODIUM LAURYL SULFATE
TITANIUM DIOXIDE
FERRIC OXIDE RED
SHELLAC
FERROSOFERRIC OXIDE
PROPYLENE GLYCOL
POTASSIUM HYDROXIDE
Product Characteristics
Color RED (red opaque) Score no score
Shape CAPSULE (size “4″ hard gelatin capsule) Size 14mm
Flavor Imprint Code LA;43
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55154-8098-0 10 BLISTER PACK in 1 BAG contains a BLISTER PACK
1 1 CAPSULE in 1 BLISTER PACK This package is contained within the BAG (55154-8098-0)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210432 07/19/2019
Labeler — Cardinal Health (603638201)
Establishment
Name Address ID/FEI Operations
Aphena Pharma Solutions — Tennessee, LLC 080089848 REPACK (55154-8097), REPACK (55154-8098)

Revised: 07/2020 Cardinal Health

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