NDC Code(s) : 42023-142-01, 42023-143-25
Packager : Par Pharmaceutical, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Trimethobenzamide Hydrochloridetrimethobenzamide hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42023-142
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
trimethobenzamide hydrochloride(UNII: WDQ5P1SX7Q)
(trimethobenzamide - UNII:W2X096QY97) 		trimethobenzamide hydrochloride100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Phenol(UNII: 339NCG44TV)
Sodium Citrate(UNII: 1Q73Q2JULR)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42023-142-011 in 1 CARTON
120 mL in 1 VIAL, MULTI-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA017530 06/01/2012 02/28/2015
Trimethobenzamide Hydrochloridetrimethobenzamide hydrochloride INJECTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42023-143
Route of Administration INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
trimethobenzamide hydrochloride(UNII: WDQ5P1SX7Q)
(trimethobenzamide - UNII:W2X096QY97) 		trimethobenzamide hydrochloride100 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Sodium Citrate(UNII: 1Q73Q2JULR)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:42023-143-2525 in 1 TRAY
12 mL in 1 VIAL, SINGLE-DOSE Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA authorized generic NDA017530 06/01/2012 12/31/2016

PRINCIPAL DISPLAY PANEL

NDC 42023-142-01

Trimethobenzamide
Hydrochloride
Injection

2,000 mg/20 mL
(100 mg/mL)

NOT FOR USE IN CHILDREN

For Intramuscular (IM) Use Only
(preferably by deep IM injection)

20 mL x 1 Multiple Dose Vial

PRINCIPAL DISPLAY PANEL - 20 mL Vial Carton

PRINCIPAL DISPLAY PANEL

NDC 42023-143-25

Trimethobenzamide
Hydrochloride
Injection

200 mg/2 mL
(100 mg/mL)

For Intramuscular
Use Only

PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton