NDC 55566-8505

Bravelle

Urofollitropin

Bravelle is a Subcutaneous Kit in the Human Prescription Drug category. It is labeled and distributed by Ferring Pharmaceuticals Inc.. The primary component is .

• Product ID: 55566-8505_af590fbf-a3fd-4b69-986b-186f8ac242bd
• NDC: 55566-8505
• Product Type: Human Prescription Drug
• Proprietary Name: Bravelle
• Generic Name: Urofollitropin
• Dosage Form: Kit
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2002-05-06
• Marketing Category: NDA / NDA
• Application Number: NDA021289
• Labeler Name: Ferring Pharmaceuticals Inc.
• Active Ingredient Strength: 0
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 55566-8505-6

1 CARTON in 1 CARTON (55566-8505-6) > 1 KIT in 1 CARTON (55566-8505-2) * 1 mL in 1 VIAL * 1 mL in 1 VIAL (0641-0495-17)

• Marketing Start Date: 2002-05-06
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55566-8505-6 [55566850506]

Bravelle KIT

• Marketing Category: NDA
• Application Number: NDA021289
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2002-05-06
• Marketing End Date: 2017-03-31

NDC 55566-8505-2 [55566850502]

Bravelle KIT

• Marketing Category: NDA
• Application Number: NDA021289
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2002-05-06
• Marketing End Date: 2017-03-31

Drug Details

OpenFDA Data

• SPL SET ID: 9bb87daf-d156-504e-adaf-4c21383f8d16
• Manufacturer:
  • Ferring Pharmaceuticals Inc.
• RxNorm Concept Unique ID - RxCUI:
  • 795143
  • 795144