NDC 55566-2800

CERVIDIL

Dinoprostone

CERVIDIL is a Vaginal Insert in the Human Prescription Drug category. It is labeled and distributed by Ferring Pharmaceuticals Inc.. The primary component is Dinoprostone.

• Product ID: 55566-2800_7aa12615-f374-e180-e053-2991aa0a9c92
• NDC: 55566-2800
• Product Type: Human Prescription Drug
• Proprietary Name: CERVIDIL
• Generic Name: Dinoprostone
• Dosage Form: Insert
• Route of Administration: VAGINAL
• Marketing Start Date: 1995-03-30
• Marketing Category: NDA / NDA
• Application Number: NDA020411
• Labeler Name: Ferring Pharmaceuticals Inc.
• Substance Name: DINOPROSTONE
• Active Ingredient Strength: 10 mg/241mg
• Pharm Classes: Prostaglandin Analog [EPC],Prostaglandins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 55566-2800-1

1 POUCH in 1 CARTON (55566-2800-1) > 10 mg in 1 POUCH (55566-2800-0)

• Marketing Start Date: 1995-03-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55566-2800-0 [55566280000]

CERVIDIL INSERT

• Marketing Category: NDA
• Application Number: NDA020411
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1995-03-30

NDC 55566-2800-2 [55566280002]

CERVIDIL INSERT

• Marketing Category: NDA
• Application Number: NDA020411
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 1995-03-30
• Marketing End Date: 2015-09-28

NDC 55566-2800-1 [55566280001]

CERVIDIL INSERT

• Marketing Category: NDA
• Application Number: NDA020411
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1995-03-30

Drug Details

Active Ingredients

Ingredient	Strength
DINOPROSTONE	10 mg/241mg

OpenFDA Data

• SPL SET ID: f3bc9031-0620-4a50-b440-f661cadfeb1d
• Manufacturer:
  • Ferring Pharmaceuticals Inc.
• UNII:
  • K7Q1JQR04M
• RxNorm Concept Unique ID - RxCUI:
  • 597959
  • 597957
• PHarm Class EPC:
  • Prostaglandin Analog [EPC]
• NUI Code:
  • N0000175454
  • N0000007706

Pharmacological Class

• Prostaglandin Analog [EPC]
• Prostaglandins [Chemical/Ingredient]
• Prostaglandins [CS]
• Prostaglandin Analog [EPC]
• Prostaglandins [CS]

NDC Crossover Matching brand name "CERVIDIL" or generic name "Dinoprostone"

NDC	Brand Name	Generic Name
55566-2800	CERVIDIL	DINOPROSTONE
0009-3359	Prepidil	dinoprostone
0009-0827	Prostin	dinoprostone