Briviact (Page 8 of 8)

PRINCIPAL DISPLAY PANEL — 10 mg Tablet Bottle Carton

NDC 50474-370-66
Rx only

BRIVIACT®
(brivaracetam)
tablets

CV

10 mg

ATTENTION PHARMACIST:
Dispense accompanyingmedication guide to each patient.

60 tablets

PRINCIPAL DISPLAY PANEL -- 10 mg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 25 mg Tablet Bottle Carton

NDC 50474-470-66
Rx only

BRIVIACT®
(brivaracetam)
tablets

CV

25 mg

ATTENTION PHARMACIST:
Dispense accompanyingmedication guide to each patient.

60 tablets

PRINCIPAL DISPLAY PANEL -- 25 mg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg Tablet Bottle Carton

NDC 50474-570-66
Rx only

BRIVIACT®
(brivaracetam)
tablets

CV

50 mg

ATTENTION PHARMACIST:
Dispense accompanyingmedication guide to each patient.

60 tablets

PRINCIPAL DISPLAY PANEL -- 50 mg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 75 mg Tablet Bottle Carton

NDC 50474-670-66
Rx only

BRIVIACT®
(brivaracetam)
tablets

CV

75 mg

ATTENTION PHARMACIST:
Dispense accompanyingmedication guide to each patient.

60 tablets

PRINCIPAL DISPLAY PANEL -- 75 mg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 100 mg Tablet Bottle Carton

NDC 50474-770-66
Rx only

BRIVIACT®
(brivaracetam)
tablets

CV

100 mg

ATTENTION PHARMACIST:
Dispense accompanyingmedication guide to each patient.

60 tablets

PRINCIPAL DISPLAY PANEL -- 100 mg Tablet Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg/mL Bottle Carton

NDC 50474-870-15
Rx only

BRIVIACT®
(brivaracetam)
oral solution
CV

10 mg/mL

ATTENTION PHARMACIST:
Dispense accompanying
medication guide to each patient

300 mL

PRINCIPAL DISPLAY PANEL -- 10 mg/mL Bottle Carton
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 50 mg/5 mL Vial Carton

NDC 50474-970-75
Rx only

BRIVIACT®
(brivaracetam) injection CV
50 mg/5 mL(10 mg/mL)

For Intravenous Use Only

10 vials

PRINCIPAL DISPLAY PANEL -- 50 mg/5 mL Vial Carton
(click image for full-size original)
BRIVIACT brivaracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50474-370
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
brivaracetam (brivaracetam) brivaracetam 10 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
lactose monohydrate
betadex
anhydrous lactose
magnesium stearate
polyvinyl alcohol, unspecified
talc
polyethylene glycol 3350
titanium dioxide
Product Characteristics
Color WHITE Score no score
Shape ROUND Size 7mm
Flavor Imprint Code u10
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50474-370-66 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (50474-370-66)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205836 05/12/2016
BRIVIACT brivaracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50474-470
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
brivaracetam (brivaracetam) brivaracetam 25 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
lactose monohydrate
betadex
anhydrous lactose
magnesium stearate
polyvinyl alcohol, unspecified
talc
polyethylene glycol 3350
titanium dioxide
ferric oxide yellow
ferrosoferric oxide
Product Characteristics
Color GRAY Score no score
Shape OVAL Size 9mm
Flavor Imprint Code u25
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50474-470-66 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (50474-470-66)
2 NDC:50474-470-09 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (50474-470-09)
3 NDC:50474-470-14 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 14 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (50474-470-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205836 05/12/2016
BRIVIACT brivaracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50474-570
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
brivaracetam (brivaracetam) brivaracetam 50 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
lactose monohydrate
betadex
anhydrous lactose
magnesium stearate
polyvinyl alcohol, unspecified
talc
polyethylene glycol 3350
titanium dioxide
ferric oxide yellow
ferric oxide red
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 12mm
Flavor Imprint Code u50
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50474-570-66 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (50474-570-66)
2 NDC:50474-570-09 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (50474-570-09)
3 NDC:50474-570-14 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 14 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (50474-570-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205836 05/12/2016
BRIVIACT brivaracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50474-670
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
brivaracetam (brivaracetam) brivaracetam 75 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
lactose monohydrate
betadex
anhydrous lactose
magnesium stearate
polyvinyl alcohol, unspecified
talc
polyethylene glycol 3350
titanium dioxide
ferric oxide yellow
ferric oxide red
ferrosoferric oxide
Product Characteristics
Color PURPLE Score no score
Shape OVAL Size 13mm
Flavor Imprint Code u75
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50474-670-66 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (50474-670-66)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205836 05/12/2016
BRIVIACT brivaracetam tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50474-770
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
brivaracetam (brivaracetam) brivaracetam 100 mg
Inactive Ingredients
Ingredient Name Strength
croscarmellose sodium
lactose monohydrate
betadex
anhydrous lactose
magnesium stearate
polyvinyl alcohol, unspecified
talc
polyethylene glycol 3350
titanium dioxide
ferric oxide yellow
ferrosoferric oxide
Product Characteristics
Color GREEN (green-grey) Score no score
Shape OVAL Size 15mm
Flavor Imprint Code u100
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50474-770-66 1 BOTTLE in 1 CARTON contains a BOTTLE
1 60 TABLET, FILM COATED in 1 BOTTLE This package is contained within the CARTON (50474-770-66)
2 NDC:50474-770-09 100 BLISTER PACK in 1 CARTON contains a BLISTER PACK
2 1 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (50474-770-09)
3 NDC:50474-770-14 1 BLISTER PACK in 1 CARTON contains a BLISTER PACK
3 14 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (50474-770-14)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205836 05/12/2016
BRIVIACT brivaracetam solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50474-870
Route of Administration ORAL DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
brivaracetam (brivaracetam) brivaracetam 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium citrate, unspecified form
anhydrous citric acid
methylparaben
carboxymethylcellulose sodium, unspecified
sucralose
sorbitol
glycerin
water
Product Characteristics
Color Score
Shape Size
Flavor RASPBERRY Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50474-870-15 1 BOTTLE in 1 CARTON contains a BOTTLE
1 300 mL in 1 BOTTLE This package is contained within the CARTON (50474-870-15)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205838 05/12/2016
BRIVIACT brivaracetam injection, suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50474-970
Route of Administration INTRAVENOUS DEA Schedule CV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
brivaracetam (brivaracetam) brivaracetam 50 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
sodium acetate
acetic acid
sodium chloride
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50474-970-75 10 VIAL, GLASS in 1 CARTON contains a VIAL, GLASS (50474-970-63)
1 NDC:50474-970-63 5 mL in 1 VIAL, GLASS This package is contained within the CARTON (50474-970-75)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205837 05/12/2016
Labeler — UCB, Inc. (028526403)

Revised: 09/2021 UCB, Inc.

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