TROSPIUM CHLORIDE (Page 6 of 6)

TROSPIUM CHLORIDE

Label ImageLabel Image
TROSPIUM CHLORIDE trospium chloride capsule, extended release
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-5994(NDC:70436-174)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TROSPIUM CHLORIDE (TROSPIUM) TROSPIUM CHLORIDE 60 mg
Inactive Ingredients
Ingredient Name Strength
ETHYLCELLULOSE, UNSPECIFIED
FD&C YELLOW NO. 6
GELATIN, UNSPECIFIED
HYPROMELLOSE, UNSPECIFIED
POLYETHYLENE GLYCOL 3350
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)
POLYSORBATE 80
POLYVINYL ALCOHOL, UNSPECIFIED
SODIUM LAURYL SULFATE
TALC
TITANIUM DIOXIDE
TRIETHYL CITRATE
FERROSOFERRIC OXIDE
POTASSIUM HYDROXIDE
SHELLAC
Product Characteristics
Color orange (opaque medium orange cap) , white (opaque white body) Score no score
Shape CAPSULE Size 21mm
Flavor Imprint Code A;126
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50090-5994-0 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA214760 06/21/2021
Labeler — A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Operations
A-S Medication Solutions 830016429 RELABEL (50090-5994), REPACK (50090-5994)

Revised: 06/2022 A-S Medication Solutions

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