NDC Code(s) : 54569-5589-0
Packager : A-S Medication Solutions

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Trimethobenzamide Hydrochloride Trimethobenzamide Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54569-5589(NDC:43386-660)
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIMETHOBENZAMIDE HYDROCHLORIDE(UNII: WDQ5P1SX7Q)
(TRIMETHOBENZAMIDE - UNII:W2X096QY97) 		TRIMETHOBENZAMIDE HYDROCHLORIDE300 mg
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
STARCH, CORN(UNII: O8232NY3SJ)
D&C RED NO. 28(UNII: 767IP0Y5NH)
GELATIN(UNII: 2G86QN327L)
FD&C BLUE NO. 1(UNII: H3R47K3TBD)
FD&C RED NO. 40(UNII: WZB9127XOA)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
LECITHIN, SOYBEAN(UNII: 1DI56QDM62)
WATER(UNII: 059QF0KO0R)
SHELLAC(UNII: 46N107B71O)
ETHYLENE GLYCOL MONOETHYL ETHER(UNII: IDK7C2HS09)
Product Characteristics
Color PURPLE (lavendar opaque cap and lavender opaque body) Score no score
Shape CAPSULE Size 14 mm
Flavor Imprint Code Novel660;300mg
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:54569-5589-012 in 1 BOTTLE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076546 01/17/2011

PRINCIPAL DISPLAY PANEL

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