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NDC 72603-0344-01 Leuprolide Acetate Details

Leuprolide Acetate

Leuprolide Acetate is a KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by NorthStar RxLLC. 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: 72603-0344-01
Last Updated: 05/19/2024
MedLinePlus Full Drug Details: Leuprolide Injection

Product Information

NDC	72603-0344
Product ID	72603-344_0cf2cd13-08b0-05cb-e063-6394a90ad325
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Leuprolide Acetate
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	NorthStar RxLLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	ANDA
Application Number	ANDA213829
Listing Certified Through	2024-12-31

Package

NDC 72603-0344-01 (72603034401)

Pricing Information	N/A
NDC Package Code	72603-344-01
Billing NDC	72603034401
Package	1 KIT in 1 CARTON (72603-344-01) * 1 VIAL, MULTI-DOSE in 1 CARTON / 2.8 mL in 1 VIAL, MULTI-DOSE * 28 PACKET in 1 CARTON / 1 mL in 1 PACKET
Marketing Start Date	2023-01-15
NDC Exclude Flag	N