Trospium Chloride (Page 6 of 6)

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 68462-461-60
TROSPIUM CHLORIDE TABLETS USP
20 mg
Pharmacist: Dispense the patient information sheet provided separately to each patient.

20mg-label
(click image for full-size original)
TROSPIUM CHLORIDE
trospium chloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68462-461
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TROSPIUM CHLORIDE (TROSPIUM) TROSPIUM CHLORIDE 20 mg
Inactive Ingredients
Ingredient Name Strength
MICROCRYSTALLINE CELLULOSE
LACTOSE MONOHYDRATE
STARCH, CORN
POVIDONE, UNSPECIFIED
CROSCARMELLOSE SODIUM
SILICON DIOXIDE
MAGNESIUM STEARATE
TITANIUM DIOXIDE
POLYETHYLENE GLYCOL 400
HYPROMELLOSE, UNSPECIFIED
FERRIC OXIDE YELLOW
FERRIC OXIDE RED
Product Characteristics
Color YELLOW (Brownish yellow) Score no score
Shape ROUND (Biconvex) Size 6mm
Flavor Imprint Code L;1
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68462-461-30 30 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:68462-461-60 60 TABLET, FILM COATED in 1 BOTTLE None
3 NDC:68462-461-05 500 TABLET, FILM COATED in 1 BOTTLE None
4 NDC:68462-461-10 1000 TABLET, FILM COATED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091575 08/13/2010
Labeler — Glenmark Pharmaceuticals Inc., USA (130597813)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 677318665 ANALYSIS (68462-461), MANUFACTURE (68462-461)
Establishment
Name Address ID/FEI Operations
Glenmark Pharmaceuticals Limited 862603186 ANALYSIS (68462-461), MANUFACTURE (68462-461)

Revised: 12/2023 Glenmark Pharmaceuticals Inc., USA

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