Tigan (Page 2 of 2)

Storage

Store between 20° to 25°C (68° to 77°F).(See USP Controlled Room Temperature.)

How Supplied

Tigan® (trimethobenzamide hydrochloride) is available as follows:

NDC 42023-119-25 100 mg/mL in 2 mL Single-Dose Vials, Pack of 25

NDC 42023-118-01 100 mg/mL in 20 mL Multi-Dose Vials, Pack of 1

Rx Only

Product repackaged by: Henry Schein, Inc., Bastian, VA 24314

From Original Manufacturer/Distributor’s NDC and Unit of Sale	To Henry Schein Repackaged Product NDC and Unit of Sale	Total Strength/Total Volume (Concentration) per unit
NDC 42023-119-25Pack of 25	NDC 0404-9964-021 2 mL Single Dose Vial in a bag(Vial bears NDC 42023-119-25)	100 mg/mL

Manufacturered by:

Par Pharmaceutical

Chestnut Ridge, NY

R04/16

3000358F

OS118J-01-90-01

Sample Package Label

TIGAN trimethobenzamide hydrochloride injection

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0404-9964(NDC:42023-119) Route of Administration INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Trimethobenzamide Hydrochloride (Trimethobenzamide) Trimethobenzamide Hydrochloride 100 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CITRATE 0.5 mg in 1 mL CITRIC ACID MONOHYDRATE 0.2 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0404-9964-02 1 VIAL, SINGLE-DOSE in 1 BAG contains a VIAL, SINGLE-DOSE 1 2 mL in 1 VIAL, SINGLE-DOSE This package is contained within the BAG (0404-9964-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017530 01/11/2022

Labeler — Henry Schein, Inc (012430880)

Revised: 10/2022 Henry Schein, Inc