CARBAMAZEPINE (Page 8 of 8)

PRINCIPAL DISPLAY PANEL

Carbamazepine 200mg tablets 30 ct blister card
(click image for full-size original)

100 mg (Carbamazepine Chewable Tablets) : label

Carbamazepine 100mg chewable tablet 30 count blister card
(click image for full-size original)
CARBAMAZEPINE carbamazepine tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-0268(NDC:13668-268)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMAZEPINE (CARBAMAZEPINE) CARBAMAZEPINE 200 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C RED NO. 40
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
Product Characteristics
Color pink Score 2 pieces
Shape CAPSULE Size 14mm
Flavor Imprint Code 268
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58118-0268-3 30 TABLET in 1 BOTTLE None
2 NDC:58118-0268-6 60 TABLET in 1 BOTTLE None
3 NDC:58118-0268-9 90 TABLET in 1 BOTTLE None
4 NDC:58118-0268-8 30 TABLET in 1 BLISTER PACK None
5 NDC:58118-0268-0 1 TABLET in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077272 10/23/2009
CARBAMAZEPINE carbamazepine tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58118-1271(NDC:13668-271)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMAZEPINE (CARBAMAZEPINE) CARBAMAZEPINE 100 mg
Inactive Ingredients
Ingredient Name Strength
SILICON DIOXIDE
FD&C RED NO. 40
HYPROMELLOSE, UNSPECIFIED
MAGNESIUM STEARATE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STARCH, CORN
SUCROSE
Product Characteristics
Color pink Score 2 pieces
Shape ROUND (circular) Size 10mm
Flavor STRAWBERRY, VANILLA Imprint Code 271
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:58118-1271-3 30 TABLET, CHEWABLE in 1 BOTTLE None
2 NDC:58118-1271-6 60 TABLET, CHEWABLE in 1 BOTTLE None
3 NDC:58118-1271-9 90 TABLET, CHEWABLE in 1 BOTTLE None
4 NDC:58118-1271-8 30 TABLET, CHEWABLE in 1 BLISTER PACK None
5 NDC:58118-1271-0 1 TABLET, CHEWABLE in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075712 08/26/2009 12/01/2018
Labeler — Clinical Solutions Wholesale (078710347)
Registrant — Clincal Solutions Wholesale (078710347)
Establishment
Name Address ID/FEI Operations
Clinical Solutions Wholesale 078710347 repack (58118-0268), repack (58118-1271), relabel (58118-0268), relabel (58118-1271)

Revised: 09/2020 Clinical Solutions Wholesale

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