Prescription Drug Information: Pregabalin (Page 10 of 10)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

25 mg-container-label-90’s-count

pregabalin-25-mg-90s-count
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50 mg-container-label-90’s-count

pregabalin-50-mg-90s-count
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75 mg-container-label-90’s-count

pregabalin-75-mg-90s-count
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100 mg-container-label-90’s-count

pregabalin-100-mg-90s-count
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150 mg-container-label-90’s-count

pregabalin-150-mg-90s-count
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200 mg-container-label-90’s-count

pregabalin-200-mg-90s-count
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225 mg-container-label-90’s-count

pregabalin-225-mg-90s-count
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300-mg-container-label-90s-count

pregabalin-300-mg-90s-count
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PREGABALIN pregabalin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72205-011
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
MANNITOL
TALC
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE (White-Light Blue) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code PGBN;25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72205-011-90 90 CAPSULE in 1 BOTTLE None
2 NDC:72205-011-99 1000 CAPSULE in 1 BOTTLE None
3 NDC:72205-011-06 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72205-011-11)
3 NDC:72205-011-11 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (72205-011-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209357 07/19/2019
PREGABALIN pregabalin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72205-012
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
MANNITOL
TALC
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE (White-Light Blue) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code PGBN;50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72205-012-90 90 CAPSULE in 1 BOTTLE None
2 NDC:72205-012-99 1000 CAPSULE in 1 BOTTLE None
3 NDC:72205-012-06 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72205-012-11)
3 NDC:72205-012-11 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (72205-012-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209357 07/19/2019
PREGABALIN pregabalin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72205-013
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
MANNITOL
TALC
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE (White-Light Blue) Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code PGBN;75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72205-013-90 90 CAPSULE in 1 BOTTLE None
2 NDC:72205-013-99 1000 CAPSULE in 1 BOTTLE None
3 NDC:72205-013-06 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72205-013-11)
3 NDC:72205-013-11 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (72205-013-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209357 07/19/2019
PREGABALIN pregabalin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72205-014
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
MANNITOL
TALC
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE (White-Light Blue) Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code PGBN;100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72205-014-90 90 CAPSULE in 1 BOTTLE None
2 NDC:72205-014-99 1000 CAPSULE in 1 BOTTLE None
3 NDC:72205-014-06 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72205-014-11)
3 NDC:72205-014-11 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (72205-014-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209357 07/19/2019
PREGABALIN pregabalin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72205-015
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
MANNITOL
TALC
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE (White-Light Blue) Score no score
Shape CAPSULE Size 18mm
Flavor Imprint Code PGBN;150
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72205-015-90 90 CAPSULE in 1 BOTTLE None
2 NDC:72205-015-05 500 CAPSULE in 1 BOTTLE None
3 NDC:72205-015-06 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72205-015-11)
3 NDC:72205-015-11 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (72205-015-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209357 07/19/2019
PREGABALIN pregabalin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72205-016
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
MANNITOL
TALC
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE (White-Light Blue) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code PGBN;200
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72205-016-90 90 CAPSULE in 1 BOTTLE None
2 NDC:72205-016-99 1000 CAPSULE in 1 BOTTLE None
3 NDC:72205-016-06 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72205-016-11)
3 NDC:72205-016-11 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (72205-016-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209357 07/19/2019
PREGABALIN pregabalin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72205-017
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
MANNITOL
TALC
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE (White-Light Blue) Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code PGBN;225
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72205-017-90 90 CAPSULE in 1 BOTTLE None
2 NDC:72205-017-99 1000 CAPSULE in 1 BOTTLE None
3 NDC:72205-017-06 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72205-017-11)
3 NDC:72205-017-11 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (72205-017-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209357 07/19/2019
PREGABALIN pregabalin capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:72205-018
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
MANNITOL
TALC
GELATIN
TITANIUM DIOXIDE
FD&C BLUE NO. 2
SHELLAC
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SODIUM LAURYL SULFATE
Product Characteristics
Color WHITE (White-Light Blue) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code PGBN;300
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:72205-018-90 90 CAPSULE in 1 BOTTLE None
2 NDC:72205-018-05 500 CAPSULE in 1 BOTTLE None
3 NDC:72205-018-06 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK (72205-018-11)
3 NDC:72205-018-11 10 CAPSULE in 1 BLISTER PACK This package is contained within the CARTON (72205-018-06)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA209357 07/19/2019
Labeler — Novadoz Pharmaceuticals LLC (081109687)
Establishment
Name Address ID/FEI Operations
MSN LABORATORIES PRIVATE LIMITED 650786952 ANALYSIS (72205-011), ANALYSIS (72205-012), ANALYSIS (72205-013), ANALYSIS (72205-014), ANALYSIS (72205-015), ANALYSIS (72205-016), ANALYSIS (72205-017), ANALYSIS (72205-018), MANUFACTURE (72205-011), MANUFACTURE (72205-012), MANUFACTURE (72205-013), MANUFACTURE (72205-014), MANUFACTURE (72205-015), MANUFACTURE (72205-016), MANUFACTURE (72205-017), MANUFACTURE (72205-018)

Revised: 06/2021 Novadoz Pharmaceuticals LLC

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