NDC Code(s) : 71205-917-30, 71205-917-60, 71205-917-90, 71205-917-00, 71205-917-72, 71205-917-55
Packager : Proficient Rx LP

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

TROSPIUM CHLORIDETROSPIUM CHLORIDE CAPSULE, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-917(NDC:70010-027)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TROSPIUM CHLORIDE(UNII: 1E6682427E)
(TROSPIUM - UNII:T4Y8ORK057) 		TROSPIUM CHLORIDE60 mg
Inactive Ingredients
Ingredient Name Strength
AMMONIA(UNII: 5138Q19F1X)
FERROSOFERRIC OXIDE(UNII: XM0M87F357)
ETHYLCELLULOSE, UNSPECIFIED(UNII: 7Z8S9VYZ4B)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
FD&C YELLOW NO. 6(UNII: H77VEI93A8)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW)(UNII: 99Q3C7L77T)
POLYETHYLENE GLYCOL, UNSPECIFIED(UNII: 3WJQ0SDW1A)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL(UNII: 6DC9Q167V3)
SHELLAC(UNII: 46N107B71O)
STARCH, CORN(UNII: O8232NY3SJ)
SODIUM LAURYL SULFATE(UNII: 368GB5141J)
SUCROSE(UNII: C151H8M554)
TALC(UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
TRIETHYL CITRATE(UNII: 8Z96QXD6UM)
Product Characteristics
Color orange (orange-white) Score no score
Shape CAPSULE Size 22 mm
Flavor Imprint Code G60;027
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:71205-917-3030 in 1 BOTTLE Type 0: Not a Combination Product07/08/2021
2NDC:71205-917-6060 in 1 BOTTLE Type 0: Not a Combination Product07/08/2021
3NDC:71205-917-9090 in 1 BOTTLE Type 0: Not a Combination Product07/08/2021
4NDC:71205-917-00100 in 1 BOTTLE Type 0: Not a Combination Product07/08/2021
5NDC:71205-917-72120 in 1 BOTTLE Type 0: Not a Combination Product07/08/2021
6NDC:71205-917-55500 in 1 BOTTLE Type 0: Not a Combination Product07/08/2021
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213185 08/19/2020

LABELER - Proficient Rx LP(079196022)

Establishment
Name Address ID/FEI Business Operations
Proficient Rx LP 079196022 REPACK(71205-917), RELABEL(71205-917)

PRINCIPAL DISPLAY PANEL

71205-917-00