Pregabalin (Page 11 of 11)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 25000-179-07
Pregabalin Capsules 25 mg 90 count bottle label

prega-25mg-90s
(click image for full-size original)

NDC 25000-180-07
Pregabalin Capsules 50 mg 90 count bottle label

prega-50mg-90s
(click image for full-size original)

NDC 25000-181-07
Pregabalin Capsules 75 mg 90 count bottle label

prega-75mg-90s
(click image for full-size original)

NDC 25000-182-07
Pregabalin Capsules 100 mg 90 count bottle label

prega-100mg-90s
(click image for full-size original)

NDC 25000-183-07
Pregabalin Capsules 150 mg 90 count bottle label

prega-150mg-90s
(click image for full-size original)

NDC 25000-184-07
Pregabalin Capsules 200 mg 90 count bottle label

prega-200mg-90s
(click image for full-size original)

NDC 25000-185-07
Pregabalin Capsules 225 mg 90 count bottle label

prega-225mg-90s
(click image for full-size original)

NDC 25000-186-07
Pregabalin Capsules 300 mg 90 count bottle label

prega-300mg-90s
(click image for full-size original)
PREGABALIN pregabalin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-179
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN (PREGABALIN) PREGABALIN 25 mg
Inactive Ingredients
Ingredient Name Strength
TALC
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
SHELLAC
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
STARCH, CORN
Product Characteristics
Color WHITE (White to off white) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 4E25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-179-07 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216197 08/01/2022
PREGABALIN pregabalin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-180
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
TALC
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
SHELLAC
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
STARCH, CORN
Product Characteristics
Color WHITE (White to off white) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 4F50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-180-07 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216197 08/01/2022
PREGABALIN pregabalin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-181
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
TALC
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
SHELLAC
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
STARCH, CORN
Product Characteristics
Color ORANGE (Orange opaque / White to off white) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code 4G75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-181-07 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216197 08/01/2022
PREGABALIN pregabalin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-182
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN (PREGABALIN) PREGABALIN 100 mg
Inactive Ingredients
Ingredient Name Strength
TALC
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
SHELLAC
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
STARCH, CORN
Product Characteristics
Color ORANGE (Orange opaque) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code 4H100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-182-07 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216197 08/01/2022
PREGABALIN pregabalin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-183
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN (PREGABALIN) PREGABALIN 150 mg
Inactive Ingredients
Ingredient Name Strength
TALC
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
SHELLAC
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
STARCH, CORN
Product Characteristics
Color WHITE (White to off white) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code 4I150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-183-07 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216197 08/01/2022
PREGABALIN pregabalin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-184
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN (PREGABALIN) PREGABALIN 200 mg
Inactive Ingredients
Ingredient Name Strength
TALC
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
SHELLAC
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
STARCH, CORN
Product Characteristics
Color ORANGE (Light orange) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 4J200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-184-07 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216197 08/01/2022
PREGABALIN pregabalin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-185
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN (PREGABALIN) PREGABALIN 225 mg
Inactive Ingredients
Ingredient Name Strength
TALC
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
SHELLAC
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
STARCH, CORN
Product Characteristics
Color ORANGE (Light orange opaque/ white to off white) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 4K225
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-185-07 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216197 08/01/2022
PREGABALIN pregabalin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:25000-186
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PREGABALIN (PREGABALIN) PREGABALIN 300 mg
Inactive Ingredients
Ingredient Name Strength
TALC
GELATIN, UNSPECIFIED
TITANIUM DIOXIDE
SHELLAC
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
FERROSOFERRIC OXIDE
STARCH, CORN
Product Characteristics
Color ORANGE (Orange opaque / White to off white) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code 4L300
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:25000-186-07 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA216197 08/01/2022
Labeler — MARKSANS PHARMA LIMITED (925822975)
Establishment
Name Address ID/FEI Operations
MARKSANS PHARMA LIMITED 925822975 MANUFACTURE (25000-179), MANUFACTURE (25000-180), MANUFACTURE (25000-181), MANUFACTURE (25000-182), MANUFACTURE (25000-183), MANUFACTURE (25000-184), MANUFACTURE (25000-185), MANUFACTURE (25000-186)

Revised: 08/2022 MARKSANS PHARMA LIMITED

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