NDC 0185-7400

Leuprolide Acetate

Leuprolide Acetate

Leuprolide Acetate is a Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Eon Labs, Inc.. The primary component is Leuprolide Acetate.

Product ID0185-7400_db12d309-92e5-47f0-84d7-aba74956f6e0
NDC0185-7400
Product TypeHuman Prescription Drug
Proprietary NameLeuprolide Acetate
Generic NameLeuprolide Acetate
Dosage FormInjection, Solution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date1998-08-04
Marketing CategoryANDA / ANDA
Application NumberANDA074728
Labeler NameEon Labs, Inc.
Substance NameLEUPROLIDE ACETATE
Active Ingredient Strength1 mg/.2mL
Pharm ClassesGonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 0185-7400-85

1 VIAL, MULTI-DOSE in 1 CARTON (0185-7400-85) > 2.8 mL in 1 VIAL, MULTI-DOSE (0185-7400-14)
Marketing Start Date1998-08-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0185-7400-14 [00185740014]

Leuprolide Acetate KIT
Marketing CategoryANDA
Application NumberANDA074728
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-01-06

NDC 0185-7400-85 [00185740085]

Leuprolide Acetate KIT
Marketing CategoryANDA
Application NumberANDA074728
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-08-04
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
LEUPROLIDE ACETATE1 mg/.2mL

OpenFDA Data

SPL SET ID:89658d24-2417-4053-a1a4-c38d32db7221
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 545835

    • Pharmacological Class

    • Gonadotropin Releasing Hormone Receptor Agonist [EPC]
    • Gonadotropin Releasing Hormone Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Leuprolide Acetate" or generic name "Leuprolide Acetate"

    NDCBrand NameGeneric Name
    0781-4003Leuprolide AcetateLeuprolide Acetate
    0185-7400Leuprolide AcetateLeuprolide Acetate
    47335-936leuprolide acetateleuprolide acetate
    0074-3346Lupron Depotleuprolide acetate
    0074-3473Lupron Depotleuprolide acetate
    0074-3641Lupron Depotleuprolide acetate
    0074-3642Lupron Depotleuprolide acetate
    0074-3663Lupron Depotleuprolide acetate
    0074-3683Lupron Depotleuprolide acetate
    0074-2108Lupron Depot-PEDleuprolide acetate
    0074-2282Lupron Depot-PEDleuprolide acetate
    0074-2440Lupron Depot-PEDleuprolide acetate
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