Zilretta™
(triamcinolone acetonide extended-release
injectable suspension)
32 mg per vial
For intra-articular injection only.
Must be reconstituted
with the supplied diluent.
flexion
Principal Display Panel - Zilretta 32mg Vial Label
PRINCIPAL DISPLAY PANEL
Principal Display Panel - Zilretta 32mg Professional Vial Label
NDC 70801-001-02 Rx Only
Zilretta™
(triamcinolone acetonide extended-release
injectable suspension)
32 mg per vial
For intra-articular injection only.
Must be reconstituted
with the supplied diluent.
flexion
Principal Display Panel - Zilretta 32mg Professional Vial Label
PRINCIPAL DISPLAY PANEL
Principal Display Panel - Zilretta Diluent 5mL Vial Label
NDC 70801-002-01 Rx Only
DILUENT
for use with Zilretta™
5 mL
Sterile single-use vial
Do not administer directly.
flexion
Principal Display Panel - Zilretta Diluent 5mL Vial Label
PRINCIPAL DISPLAY PANEL
Principal Display Panel - Zilretta Diluent 5mL Professional Vial Label
NDC 70801-002-02 Rx Only
DILUENT
for use with Zilretta™
5 mL
Sterile single-use vial
Do not administer directly.
flexion
Principal Display Panel - Zilretta Diluent 5mL Professional Vial Label
INGREDIENTS AND APPEARANC
ZILRETTA
triamcinolone acetonide extended-release injectable suspension kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70801-003
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:70801-003-01 1 in 1 CARTON; Type 1: Convenience Kit of Co-Package 10/06/2017
2
NDC:70801-003-02 1 in 1 CARTON; Type 1: Convenience Kit of Co-Package 10/06/2017
Quantity of Parts
Part #
Package Quantity
Total Product Quantity
Part 1 1 VIAL, SINGLE-DOSE 1
Part 2 1 VIAL, SINGLE-DOSE 1
Part 1 of 2
ZILRETTA
triamcinolone acetonide injection, powder, for suspension, extended release
Product Information
Item Code (Source) NDC:70801-001
Route of Administration INTRA-ARTICULAR
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA) TRIAMCINOLONE ACETONIDE 32 mg
Inactive Ingredients
Ingredient Name
Strength
POLY(DL-LACTIC-CO-GLYCOLIC ACID), (75:25; 140000 MW) (UNII: 1SIA8062RS)
Packaging
#
Item Code
Package Description
Marketing Start Date
Marketing End Date
1
NDC:70801-001-01 1 in 1 VIAL, SINGLE-DOSE; Type 0: Not a Combination Product
2
NDC:70801-001-02 1 in 1 VIAL, SING