NDC 67979-002

SUPPRELIN LA

Histrelin Acetate

SUPPRELIN LA is a Subcutaneous Implant in the Human Prescription Drug category. It is labeled and distributed by Endo Pharmaceuticals Inc.. The primary component is Histrelin Acetate.

• Product ID: 67979-002_068198e6-88f0-4662-8fed-0f3ca81be3ee
• NDC: 67979-002
• Product Type: Human Prescription Drug
• Proprietary Name: SUPPRELIN LA
• Generic Name: Histrelin Acetate
• Dosage Form: Implant
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2007-05-31
• Marketing Category: NDA / NDA
• Application Number: NDA022058
• Labeler Name: Endo Pharmaceuticals Inc.
• Substance Name: HISTRELIN ACETATE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Gonadotropin Releasing Hormone Receptor Agonist [EPC],Gonadotropin Releasing Hormone Receptor Agonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 67979-002-01

1 VIAL, GLASS in 1 CARTON (67979-002-01) > 1 IMPLANT in 1 VIAL, GLASS

• Marketing Start Date: 2007-05-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67979-002-01 [67979000201]

SUPPRELIN LA IMPLANT

• Marketing Category: NDA
• Application Number: NDA022058
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2007-05-31

Drug Details

Active Ingredients

Ingredient	Strength
HISTRELIN ACETATE	50 mg/1

OpenFDA Data

• SPL SET ID: d8fb000e-3cc9-4803-b71d-2cc597661977
• Manufacturer:
  • Endo Pharmaceuticals Solutions Inc.
• UNII:
  • QMG7HLD1ZE
• RxNorm Concept Unique ID - RxCUI:
  • 1294641
  • 1740437
• UPC Code:
  • 0367979002016

Pharmacological Class

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

NDC Crossover Matching brand name "SUPPRELIN LA" or generic name "Histrelin Acetate"

NDC	Brand Name	Generic Name
67979-002	SUPPRELIN	histrelin acetate
67979-500	Vantas	histrelin acetate