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 ID: 50090-2027_9c6f030b-8965-45e6-bcb5-7bf12d129abe
• NDC: 50090-2027
• Product Type: Human Prescription Drug
• Proprietary Name: ZOLADEX
• Generic Name: Goserelin Acetate
• Dosage Form: Implant
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2003-05-05
• Marketing Category: NDA / NDA
• Application Number: NDA019726
• Labeler Name: A-S Medication Solutions
• Substance Name: GOSERELIN ACETATE
• Active Ingredient Strength: 4 mg/1
• Pharm Classes: Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 50090-2027-0

1 POUCH in 1 CARTON (50090-2027-0) > 1 IMPLANT in 1 POUCH

• Marketing Start Date: 2015-09-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-2027-0 [50090202700]

ZOLADEX IMPLANT

• Marketing Category: NDA
• Application Number: NDA019726
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2015-09-23
• Marketing End Date: 2019-10-31

Drug Details

Active Ingredients

Ingredient	Strength
GOSERELIN ACETATE	3.6 mg/1

OpenFDA Data

• SPL SET ID: 5069faa5-a803-4193-b16a-df27b13c500c
• Manufacturer:
  • A-S Medication Solutions
• UNII:
  • 6YUU2PV0U8
• 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"

NDC	Brand Name	Generic Name
0310-0950	ZOLADEX	Goserelin acetate
0310-0951	ZOLADEX	Goserelin acetate
50090-2027	ZOLADEX	Goserelin acetate
50090-3466	ZOLADEX	goserelin acetate
70720-950	ZOLADEX	goserelin acetate
70720-951	ZOLADEX	goserelin acetate