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

Manufacturered by:

Par Pharmaceutical

Chestnut Ridge, NY

R04/16

3000358F

OS118J-01-90-01

Sample Package Label

//medlibrary.org/lib/images-rx/tigan-4/label1-300x275.jpg
(click image for full-size original)

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: 01/2022 Henry Schein, Inc

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