NDC 0781-4003

Leuprolide Acetate

Leuprolide Acetate

Leuprolide Acetate is a Kit in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is .

Product ID0781-4003_b714c3e7-31c7-4345-be7c-c4aae0da6b05
NDC0781-4003
Product TypeHuman Prescription Drug
Proprietary NameLeuprolide Acetate
Generic NameLeuprolide Acetate
Dosage FormKit
Marketing Start Date1998-08-04
Marketing CategoryANDA / ANDA
Application NumberANDA074728
Labeler NameSandoz Inc
Active Ingredient Strength0
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0781-4003-32

1 KIT in 1 CARTON (0781-4003-32) * 1 VIAL, MULTI-DOSE in 1 CARTON (0781-3006-42) > 2.8 mL in 1 VIAL, MULTI-DOSE * 1 mL in 1 PACKET
Marketing Start Date1998-08-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-4003-32 [00781400332]

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

Drug Details

OpenFDA Data

SPL SET ID:8bd72c1e-2751-4498-a346-bc5e3acbba0b
Manufacturer
RxNorm Concept Unique ID - RxCUI
  • 797544
  • 545835
    • UPC Code
  • 0307813006428

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.