NDC 0009-3359

Prepidil

Dinoprostone

Prepidil is a Vaginal Gel in the Human Prescription Drug category. It is labeled and distributed by Pharmacia And Upjohn Company Llc. The primary component is Dinoprostone.

• Product ID: 0009-3359_266f0ff5-e301-4387-be52-be9535c36d7c
• NDC: 0009-3359
• Product Type: Human Prescription Drug
• Proprietary Name: Prepidil
• Generic Name: Dinoprostone
• Dosage Form: Gel
• Route of Administration: VAGINAL
• Marketing Start Date: 1992-12-09
• Marketing Category: NDA / NDA
• Application Number: NDA019617
• Labeler Name: Pharmacia and Upjohn Company LLC
• Substance Name: DINOPROSTONE
• Active Ingredient Strength: 1 mg/3g
• Pharm Classes: Prostaglandin Analog [EPC],Prostaglandins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0009-3359-01

1 SYRINGE in 1 CARTON (0009-3359-01) > 3 g in 1 SYRINGE

• Marketing Start Date: 2019-12-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0009-3359-02 [00009335902]

Prepidil GEL

• Marketing Category: NDA
• Application Number: NDA019617
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 1992-12-09

NDC 0009-3359-01 [00009335901]

Prepidil GEL

• Marketing Category: NDA
• Application Number: NDA019617
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2019-12-11

Drug Details

Active Ingredients

Ingredient	Strength
DINOPROSTONE	.5 mg/3g

OpenFDA Data

• SPL SET ID: ab03de5b-782c-4f81-a8dc-7ef9969dd0cf
• Manufacturer:
  • Pharmacia and Upjohn Company LLC
• UNII:
  • K7Q1JQR04M
• RxNorm Concept Unique ID - RxCUI:
  • 309922
  • 208397
• PHarm Class EPC:
  • Prostaglandin Analog [EPC]
• UPC Code:
  • 0300093359024
• NUI Code:
  • N0000175454
  • N0000007706

Pharmacological Class

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

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

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