NDC 0310-0950

ZOLADEX

Goserelin Acetate

ZOLADEX is a Subcutaneous Implant in the Human Prescription Drug category. It is labeled and distributed by Astrazeneca Pharmaceuticals Lp. The primary component is Goserelin Acetate.

• Product ID: 0310-0950_46b6a91f-557e-42f6-a4d5-b10705314542
• NDC: 0310-0950
• 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 End Date: 2020-05-31
• Marketing Category: NDA / NDA
• Application Number: NDA019726
• Labeler Name: AstraZeneca Pharmaceuticals LP
• 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

Packaging

NDC 0310-0950-36

1 POUCH in 1 CARTON (0310-0950-36) > 1 SYRINGE in 1 POUCH > 1 IMPLANT in 1 SYRINGE

• Marketing Start Date: 2003-05-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0310-0950-36 [00310095036]

ZOLADEX IMPLANT

• Marketing Category: NDA
• Application Number: NDA019726
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-05-05
• Marketing End Date: 2020-05-31

Drug Details

Active Ingredients

Ingredient	Strength
GOSERELIN ACETATE	3.6 mg/1

OpenFDA Data

• SPL SET ID: 6bd94a89-f18a-45e5-d0a4-b343a4f0f03d
• Manufacturer:
  • AstraZeneca Pharmaceuticals LP
• UNII:
  • 6YUU2PV0U8
• RxNorm Concept Unique ID - RxCUI:
  • 105641
  • 310592

Pharmacological Class

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