NDC 50090-2027

ZOLADEX

Goserelin Acetate

ZOLADEX is a Subcutaneous Implant in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Goserelin Acetate.

Product ID50090-2027_9c6f030b-8965-45e6-bcb5-7bf12d129abe
NDC50090-2027
Product TypeHuman Prescription Drug
Proprietary NameZOLADEX
Generic NameGoserelin Acetate
Dosage FormImplant
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2003-05-05
Marketing CategoryNDA / NDA
Application NumberNDA019726
Labeler NameA-S Medication Solutions
Substance NameGOSERELIN ACETATE
Active Ingredient Strength4 mg/1
Pharm ClassesGonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50090-2027-0

1 POUCH in 1 CARTON (50090-2027-0) > 1 IMPLANT in 1 POUCH
Marketing Start Date2015-09-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-2027-0 [50090202700]

ZOLADEX IMPLANT
Marketing CategoryNDA
Application NumberNDA019726
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-09-23
Marketing End Date2019-10-31

Drug Details

Active Ingredients

IngredientStrength
GOSERELIN ACETATE3.6 mg/1

OpenFDA Data

SPL SET ID:5069faa5-a803-4193-b16a-df27b13c500c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 105641
  • 310592
  • Pharmacological Class

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

    NDC Crossover Matching brand name "ZOLADEX" or generic name "Goserelin Acetate"

    NDCBrand NameGeneric Name
    0310-0950ZOLADEXGoserelin acetate
    0310-0951ZOLADEXGoserelin acetate
    50090-2027ZOLADEXGoserelin acetate
    50090-3466ZOLADEXgoserelin acetate
    70720-950ZOLADEXgoserelin acetate
    70720-951ZOLADEXgoserelin acetate

    Trademark Results [ZOLADEX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZOLADEX
    ZOLADEX
    74588633 1938346 Dead/Cancelled
    Zeneca Limited
    1994-10-21
    ZOLADEX
    ZOLADEX
    74324147 1885525 Dead/Cancelled
    Zeneca Limited
    1992-10-21
    ZOLADEX
    ZOLADEX
    74010646 1624402 Live/Registered
    IMPERIAL CHEMICAL INDUSTRIES PLC
    1989-12-14
    ZOLADEX
    ZOLADEX
    73545833 1402790 Live/Registered
    IMPERIAL CHEMICAL INDUSTRIES PLC
    1985-07-01

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