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NDC 69448-0014-63 CAMCEVI 42 mg/.37g Details
CAMCEVI 42 mg/.37g
CAMCEVI is a SUBCUTANEOUS INJECTION, EMULSION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Accord BioPharma, Inc.. The primary component is LEUPROLIDE MESYLATE.
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: 69448-0014-63Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Leuprolide Injection
Product Information
| NDC | 69448-0014 |
|---|---|
| Product ID | 69448-014_f86fb59e-2cfd-e617-e053-6394a90ae577 |
| Associated GPIs | 2140501055E420 |
| GCN Sequence Number | 082352 |
| GCN Sequence Number Description | leuprolide mesylate SYRINGE 42 MG SUBCUT |
| HIC3 | V1O |
| HIC3 Description | ANTINEOPLASTIC LHRH(GNRH) AGONIST,PITUITARY SUPPR. |
| GCN | 49745 |
| HICL Sequence Number | 047414 |
| HICL Sequence Number Description | LEUPROLIDE MESYLATE |
| Brand/Generic | Brand |
| Proprietary Name | CAMCEVI |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | LEUPROLIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, EMULSION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 42 |
| Active Ingredient Units | mg/.37g |
| Substance Name | LEUPROLIDE MESYLATE |
| Labeler Name | Accord BioPharma, Inc. |
| Pharmaceutical Class | Gonadotropin Releasing Hormone Receptor Agonist [EPC], Gonadotropin Releasing Hormone Receptor Agonists [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA211488 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69448-0014-63 (69448001463)
| NDC Package Code | 69448-014-63 |
|---|---|
| Billing NDC | 69448001463 |
| Package | 1 SYRINGE in 1 CARTON (69448-014-63) / .37 g in 1 SYRINGE |
| Marketing Start Date | 2022-04-05 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |