Hexatrione

HEXATRIONE 2%- triamcinolone hexacetonide injection, suspension
Medexus Pharma, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Hexatrione

DHCP_01 DHCP_02 DHCP_03 DHCP_04 DHCP_05 DHCP_06 DHCP_07 DHCP_08 DHCP_09 DHCP_10 DHCP_11 DHCP_12 DHCP_13 DHCP_14 DHCP_15 DHCP_16 DHCP_17 DHCP_18 DHCP_19 DHCP_20 DHCP_21 DHCP_22 DHCP_23 DHCP_24 DHCP_25 DHCP_26

NDC 59137-570-01

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

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

Ampoule Label

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

Carton

HEXATRIONE 2%
triamcinolone hexacetonide injection, suspension

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
Unapproved drug for use in drug shortage		03/03/2021

Labeler - Medexus Pharma, Inc. (078811131)

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