NDC Code(s) : 17856-0241-1, 17856-0241-3, 17856-0241-5
Packager : Atlantic Biologicals Corps.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Levetiracetamlevetiracetam SOLUTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17856-0241(NDC:50383-241)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
levetiracetam(UNII: 44YRR34555)
(levetiracetam - UNII:44YRR34555) 		levetiracetam100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
ACESULFAME POTASSIUM(UNII: 23OV73Q5G9)
AMMONIUM GLYCYRRHIZATE(UNII: 3VRD35U26C)
ANHYDROUS CITRIC ACID(UNII: XF417D3PSL)
GLYCERIN(UNII: PDC6A3C0OX)
MALTITOL(UNII: D65DG142WK)
METHYLPARABEN(UNII: A2I8C7HI9T)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
WATER(UNII: 059QF0KO0R)
TRISODIUM CITRATE DIHYDRATE(UNII: B22547B95K)
Product Characteristics
Color Score
Shape Size
Flavor GRAPE Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:17856-0241-110 mL in 1 CUP Type 0: Not a Combination Product16/09/2019
2NDC:17856-0241-315 mL in 1 CUP Type 0: Not a Combination Product16/09/2019
3NDC:17856-0241-55 mL in 1 CUP Type 0: Not a Combination Product16/09/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA090601 02/28/2012

LABELER - Atlantic Biologicals Corps.(047437707)

REGISTRANT - Atlantic Biologicals Corps(047437707)

Establishment
Name Address ID/FEI Business Operations
Atlantic Biologicals Corps. 047437707 RELABEL(17856-0241), REPACK(17856-0241)

PRINCIPAL DISPLAY PANEL

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