Carbamazepine (Page 8 of 8)

CARBAMAZEPINE TABLET, CHEWABLE CARBAMAZEPINE TABLET CARBAMAZEPINE TABLET, EXTENDED RELEASE CARBAMAZEPINE SUSPENSION

Label Image
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CARBAMAZEPINE
carbamazepine suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17856-4047(NDC:51672-4047)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Carbamazepine (Carbamazepine) Carbamazepine 100 mg in 5 mL
Inactive Ingredients
Ingredient Name Strength
citric acid monohydrate
FD&C yellow no. 6
poloxamer 188
potassium sorbate
propylene glycol
water
sorbitol
sucrose
xanthan gum
Product Characteristics
Color ORANGE Score
Shape Size
Flavor ORANGE Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:17856-4047-1 10 mL in 1 CUP None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076729 09/20/2004
Labeler — Atlantic Biologicals Corps (047437707)
Registrant — Atlantic Biologicals Corps (047437707)
Establishment
Name Address ID/FEI Operations
Atlantic Biologicals Corps 047437707 RELABEL (17856-4047), REPACK (17856-4047)

Revised: 04/2016 Atlantic Biologicals Corps

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