NDC Code(s) : 71335-0800-3, 71335-0800-1, 71335-0800-2
Packager : Bryant Ranch Prepack

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Trimethobenzamide HydrochlorideTrimethobenzamide Hydrochloride CAPSULE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71335-0800(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, UNSPECIFIED(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:71335-0800-330 in 1 BOTTLE Type 0: Not a Combination Product01/12/2012
2NDC:71335-0800-110 in 1 BOTTLE Type 0: Not a Combination Product01/12/2012
3NDC:71335-0800-215 in 1 BOTTLE Type 0: Not a Combination Product01/12/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076546 01/17/2011

LABELER - Bryant Ranch Prepack(171714327)

Establishment
Name Address ID/FEI Business Operations
Bryant Ranch Prepack 171714327 REPACK(71335-0800), RELABEL(71335-0800)

PRINCIPAL DISPLAY PANEL

Label Image