Triamcinolone Acetonide (Page 5 of 5)

PRINCIPAL DISPLAY PANEL

NDC:16714-130-25

Triamcinolone acetonide injectable suspension USP, 40 mg per mL

Rx OnlyNorthstar Rx LLC

25 x 1 mL Carton Label

PRINCIPAL DISPLAY PANEL

NDC:16714-140-01

Triamcinolone acetonide injectable suspension USP, 40 mg per 5 mL

Rx OnlyNorthstar Rx LLC

Container Label

PRINCIPAL DISPLAY PANEL

NDC:16714-140-01

Triamcinolone acetonide injectable suspension USP, 40 mg per 5 mL

Rx Only
Northstar Rx LLC

Carton Label

PRINCIPAL DISPLAY PANEL

NDC:16714-150-01

Triamcinolone acetonide injectable suspension USP, 40 mg per 10 mL

Rx OnlyNorthstar Rx LLC

Container Label

PRINCIPAL DISPLAY PANEL

NDC:16714-150-01

Triamcinolone acetonide injectable suspension USP, 40 mg per 10 mL

Rx Only
Northstar Rx LLC

Carton Label

TRIAMCINOLONE ACETONIDE triamcinolone acetonide injection, suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-130 Route of Administration INTRA-ARTICULAR, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE 40 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE CARBOXYMETHYLCELLULOSE SODIUM BENZYL ALCOHOL POLYSORBATE 80 SODIUM HYDROXIDE HYDROCHLORIC ACID

Product Characteristics Color white (white to off-white) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:16714-130-01 1 VIAL in 1 CARTON contains a VIAL 1 1 mL in 1 VIAL This package is contained within the CARTON (16714-130-01) 2 NDC:16714-130-25 25 VIAL in 1 CARTON contains a VIAL 2 1 mL in 1 VIAL This package is contained within the CARTON (16714-130-25)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207550 11/19/2019

TRIAMCINOLONE ACETONIDE triamcinolone acetonide injection, suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-140 Route of Administration INTRA-ARTICULAR, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE 200 mg in 5 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE CARBOXYMETHYLCELLULOSE SODIUM BENZYL ALCOHOL POLYSORBATE 80 SODIUM HYDROXIDE HYDROCHLORIC ACID

Product Characteristics Color white (white to off-white) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:16714-140-01 1 VIAL in 1 CARTON contains a VIAL 1 5 mL in 1 VIAL This package is contained within the CARTON (16714-140-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207550 11/19/2019

TRIAMCINOLONE ACETONIDE triamcinolone acetonide injection, suspension

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16714-150 Route of Administration INTRA-ARTICULAR, INTRAMUSCULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE 400 mg in 10 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE CARBOXYMETHYLCELLULOSE SODIUM BENZYL ALCOHOL POLYSORBATE 80 SODIUM HYDROXIDE HYDROCHLORIC ACID

Product Characteristics Color white (white to off-white) Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:16714-150-01 1 VIAL in 1 CARTON contains a VIAL 1 10 mL in 1 VIAL This package is contained within the CARTON (16714-150-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA207550 11/19/2019

Labeler — NorthStar Rx LLC (830546433)

Establishment
Name	Address	ID/FEI	Operations
Amneal Pharmaceuticals Private Limited		860156658	analysis (16714-130), analysis (16714-140), analysis (16714-150), manufacture (16714-130), manufacture (16714-140), manufacture (16714-150), pack (16714-130), pack (16714-140), pack (16714-150), sterilize (16714-130), sterilize (16714-140), sterilize (16714-150)

Revised: 12/2022 NorthStar Rx LLC