Carbamazepine (Page 6 of 6)

Package Label Principal Display Panel

Carbamazepeine ER 300 mg capsule label
(click image for full-size original)

CARBAMAZEPINE carbamazepine capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:69189-0410(NDC:66993-409)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CARBAMAZEPINE (CARBAMAZEPINE) CARBAMAZEPINE 300 mg
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE
SILICON DIOXIDE
LACTOSE MONOHYDRATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOLS
POVIDONE
SODIUM LAURYL SULFATE
TALC
TRIETHYL CITRATE
GELATIN
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
TITANIUM DIOXIDE
Product Characteristics
Color BLACK (black) , GREEN (green) Score no score
Shape CAPSULE (CAPSULE) Size 22mm
Flavor Imprint Code S433;300mg
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:69189-0410-1 1 CAPSULE, EXTENDED RELEASE in 1 DOSE PACK None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA AUTHORIZED GENERIC NDA020712 06/08/2015
Labeler — Avera McKennan Hospital (068647668)
Establishment
Name Address ID/FEI Operations
Avera McKennan Hospital 068647668 relabel (69189-0410), repack (69189-0410)

Revised: 01/2016 Avera McKennan Hospital

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.