Prolia (Page 9 of 9)

PRINCIPAL DISPLAY PANEL

1 x 60 mg Single-Dose Prefilled Syringe
NDC 55513-710-01
AMGEN®
prolia®
(denosumab)
60 mg/mL
60 mg/mL Injection – For Subcutaneous Use Only.
Single-dose Prefilled Syringe. Discard unused portion.
Sterile Solution – No Preservative.
Rx Only
Refrigerate at 2° to 8°C (36° to 46°F). Do not freeze. Avoid excessive shaking. Protect from direct light and heat.
This Product Contains Dry Natural Rubber.Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799

Product of Singapore

PRINCIPAL DISPLAY PANEL 1 x 60 mg Single-Dose Prefilled Syringe NDC 55513-710-01 AMGEN® prolia® (denosumab) 60 mg/mL 60 mg/mL Injection – For Subcutaneous Use Only. Single-dose Prefilled Syringe.  Discard unused portion. Sterile Solution – No Preservative. Rx Only Refrigerate at 2° to 8°C (36° to 46°F). Do not freeze. Avoid excessive shaking. Protect from direct light and heat. This Product Contains Dry Natural Rubber. Manufactured by: Amgen Inc., Thousand Oaks, CA 91320-1799 Product of Singapore
(click image for full-size original)

PROLIA denosumab injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55513-710
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DENOSUMAB (DENOSUMAB) DENOSUMAB 60 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SORBITOL 47 mg in 1 mL
SODIUM ACETATE 1 mg in 1 mL
POLYSORBATE 20 0.1 mg in 1 mL
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55513-710-01 1 SYRINGE in 1 CARTON contains a SYRINGE
1 1 mL in 1 SYRINGE This package is contained within the CARTON (55513-710-01)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
BLA BLA125320 06/05/2010
Labeler — Amgen Inc (039976196)
Establishment
Name Address ID/FEI Operations
Amgen Manufacturing Ltd 785800020 ANALYSIS (55513-710), LABEL (55513-710), MANUFACTURE (55513-710), PACK (55513-710)

Revised: 05/2021 Amgen Inc

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