NDC 50090-3466

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: 50090-3466_85bc1c89-64e7-49f1-ad4e-a7c634dbf0da
• NDC: 50090-3466
• Product Type: Human Prescription Drug
• Proprietary Name: ZOLADEX
• Generic Name: Goserelin Acetate
• Dosage Form: Implant
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2018-03-31
• 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: 2022-12-31

Packaging

NDC 50090-3466-0

1 POUCH in 1 CARTON (50090-3466-0) > 1 IMPLANT in 1 POUCH

• Marketing Start Date: 2018-05-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50090-3466-0 [50090346600]

ZOLADEX IMPLANT

• Marketing Category: NDA
• Application Number: NDA019726
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-05-30

Drug Details

Active Ingredients

Ingredient	Strength
GOSERELIN ACETATE	3.6 mg/1

OpenFDA Data

• SPL SET ID: a906a5bd-d2ec-4e35-8962-c0c86c637630
• 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