Chlordiazepoxide Hydrochloride (Page 3 of 3)

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CHLORDIAZEPOXIDE HYDROCHLORIDE
chlordiazepoxide hydrochloride capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53217-183(NDC:0555-0159)
Route of Administration ORAL DEA Schedule CIV
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORDIAZEPOXIDE HYDROCHLORIDE (CHLORDIAZEPOXIDE) CHLORDIAZEPOXIDE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS LACTOSE
D&C YELLOW NO. 10
FD&C BLUE NO. 1
GELATIN, UNSPECIFIED
HYDROGENATED COTTONSEED OIL
MICROCRYSTALLINE CELLULOSE
SHELLAC
TITANIUM DIOXIDE
FD&C BLUE NO. 2
INDIGOTINDISULFONATE SODIUM
FD&C RED NO. 40
PROPYLENE GLYCOL
FERROSOFERRIC OXIDE
Product Characteristics
Color GREEN (aqua green) , WHITE Score no score
Shape CAPSULE Size 14mm
Flavor Imprint Code barr;159
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53217-183-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA084769 07/01/1976
Labeler — Aidarex Pharmaceuticals LLC (801503249)

Revised: 03/2017 Aidarex Pharmaceuticals LLC

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