HEXATRIONE 2%- triamcinolone hexacetonide injection, suspension

Hexatrione by

Drug Labeling and Warnings

Hexatrione by is a Prescription medication manufactured, distributed, or labeled by Medexus Pharma, Inc., Valdepharm. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HEALTH CARE PROVIDER LETTER

HOW SUPPLIED

NDC: 59137-570-01

• 2 mL single-dose ampoule (40 mg/2mL). One ampoule per carton.

PRINCIPAL DISPLAY PANEL

20 mg/mL (2 mL Ampoule) - Ampoule Label

20 mg/mL (2 mL Ampoule) - Carton Label

INGREDIENTS AND APPEARANCE

HEXATRIONE  2%
triamcinolone hexacetonide injection, suspension

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 59137-570
Route of Administration	INTRA-ARTICULAR

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TRIAMCINOLONE HEXACETONIDE (UNII: I7GT1U99Y9) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)	TRIAMCINOLONE HEXACETONIDE	40 mg  in 2 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SORBITOL SOLUTION 70% (UNII: 8KW3E207O2)
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59137-570-01	1 in 1 CARTON	03/03/2021
1		2 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug for use in drug shortage		03/03/2021

Labeler - Medexus Pharma, Inc. (078811131)

Establishment
Name	Address	ID/FEI	Business Operations
Valdepharm		260128560	manufacture(59137-570)