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NDC 55513-0710-01 Prolia 60 mg/mL Details
Prolia 60 mg/mL
Prolia is a SUBCUTANEOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Amgen Inc. The primary component is DENOSUMAB.
MedlinePlus Drug Summary
Denosumab injection (Prolia) is used to treat osteoporosis (a condition in which the bones become thin and weak and break easily) in women who have undergone menopause (''change of life;'' end of menstrual periods) who have an increased risk for fractures (broken bones) or who cannot take or did not respond to other medication treatments for osteoporosis. to treat men who have an increased risk for fractures (broken bones) or who cannot take or did not respond to other medication treatments for osteoporosis. treat osteoporosis that is caused by corticosteroid medications in men and women who will be taking corticosteroid medications for at least 6 months and have an increased risk for fractures or who cannot take or did not respond to other medication treatments for osteoporosis. to treat bone loss in men who are being treated for prostate cancer with certain medications that cause bone loss, to treat bone loss in women with breast cancer who are receiving certain medications that increase their risk for fractures. Denosumab injection (Xgeva) is used to reduce the risk of fractures in people who have multiple myeloma (cancer that begins in the plasma cells and causes bone damage), and in people who have certain types of cancer that began in another part of the body but has spread to the bones. in adults and some adolescents to treat giant cell tumor of bone (GCTB; a type of bone tumor) that cannot be treated with surgery. to treat high calcium levels that are caused by cancer in people who did not respond to other medications.Denosumab injection is in a class of medications called RANK ligand inhibitors. It works to prevent bone loss by blocking a certain receptor in the body to decrease bone breakdown. It works to treat GCTB by blocking a certain receptor in the tumor cells which slows the tumor growth. It works to treat high calcium levels by decreasing bone breakdown as the breakdown of bones releases calcium.
Related Packages: 55513-0710-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Denosumab Injection
Product Information
NDC | 55513-0710 |
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Product ID | 55513-710_1cebc74b-6c5c-4fa7-9f16-59f4695e29ee |
Associated GPIs | 3004453000E520 |
GCN Sequence Number | 066396 |
GCN Sequence Number Description | denosumab SYRINGE 60 MG/ML SUBCUT |
HIC3 | P4L |
HIC3 Description | BONE RESORPTION INHIBITORS |
GCN | 28656 |
HICL Sequence Number | 037012 |
HICL Sequence Number Description | DENOSUMAB |
Brand/Generic | Brand |
Proprietary Name | Prolia |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | denosumab |
Product Type | HUMAN PRESCRIPTION DRUG |
Dosage Form | INJECTION |
Route | SUBCUTANEOUS |
Active Ingredient Strength | 60 |
Active Ingredient Units | mg/mL |
Substance Name | DENOSUMAB |
Labeler Name | Amgen Inc |
Pharmaceutical Class | RANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC] |
DEA Schedule | n/a |
Marketing Category | BLA |
Application Number | BLA125320 |
Listing Certified Through | 2024-12-31 |
Package
NDC 55513-0710-01 (55513071001)
NDC Package Code | 55513-710-01 |
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Billing NDC | 55513071001 |
Package | 1 SYRINGE in 1 CARTON (55513-710-01) / 1 mL in 1 SYRINGE |
Marketing Start Date | 2010-06-05 |
NDC Exclude Flag | N |
Pricing Information | |
Price Per Unit | 1679.33 |
Pricing Unit | ML |
Effective Date | 2024-01-05 |
NDC Description | PROLIA 60 MG/ML SYRINGE |
Pharmacy Type Indicator | C/I |
OTC | N |
Explanation Code | 4, 5 |
Classification for Rate Setting | B |
As of Date | 2024-02-21 |