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NDC 69097-0909-50 LEUPROLIDE ACETATE DEPOT Details
LEUPROLIDE ACETATE DEPOT
LEUPROLIDE ACETATE DEPOT is a KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by CIPLA USA INC.. The primary component is .
MedlinePlus Drug Summary
Leuprolide injection (Eligard, Lupron Depot) is used to treat the symptoms associated with advanced prostate cancer. Leuprolide injection (Lupron Depot-PED, Fensolvi) is used in children 2 years of age or older to treat central precocious puberty (CPP; a condition causing girls [usually younger than 8 years of age] and boys [usually younger than 9 years of age] to enter puberty too soon, resulting in faster than normal bone growth and development of sexual characteristics). Leuprolide injection (Lupron Depot) is used alone or with another medication (norethindrone) to treat endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes pain, heavy or irregular menstruation [periods], and other symptoms). Leuprolide injection (Lupron Depot) is also used with other medication to treat anemia (a lower than normal number of red blood cells) caused by uterine fibroids (noncancerous growths in the uterus). Leuprolide injection is in a class of medications called gonadotropin-releasing hormone (GnRH) agonists. It works by decreasing the amount of certain hormones in the body.
Related Packages: 69097-0909-50Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Leuprolide Injection
Product Information
| NDC | 69097-0909 |
|---|---|
| Product ID | 69097-909_cd91db22-5bb6-4fae-9b5a-95a82c35931a |
| Associated GPIs | |
| GCN Sequence Number | 044965 |
| GCN Sequence Number Description | leuprolide acetate VIAL 22.5 MG INTRAMUSC |
| HIC3 | V1O |
| HIC3 Description | ANTINEOPLASTIC LHRH(GNRH) AGONIST,PITUITARY SUPPR. |
| GCN | 84594 |
| HICL Sequence Number | 021102 |
| HICL Sequence Number Description | LEUPROLIDE ACETATE |
| Brand/Generic | Generic |
| Proprietary Name | LEUPROLIDE ACETATE DEPOT |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | leuprolide acetate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | KIT |
| Route | n/a |
| Active Ingredient Strength | n/a |
| Active Ingredient Units | n/a |
| Substance Name | n/a |
| Labeler Name | CIPLA USA INC. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA205054 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69097-0909-50 (69097090950)
| NDC Package Code | 69097-909-50 |
|---|---|
| Billing NDC | 69097090950 |
| Package | 1 KIT in 1 CARTON (69097-909-50) * 2 mL in 1 VIAL, SINGLE-DOSE (69097-950-32) * 2 mL in 1 SYRINGE (69097-960-31) |
| Marketing Start Date | 2022-07-15 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |