NDC 0009-0827

Prostin E2

Dinoprostone

Prostin E2 is a Vaginal Suppository in the Human Prescription Drug category. It is labeled and distributed by Pharmacia And Upjohn Company Llc. The primary component is Dinoprostone.

• Product ID: 0009-0827_058a1011-a6ac-44e5-9146-856e0b68ed98
• NDC: 0009-0827
• Product Type: Human Prescription Drug
• Proprietary Name: Prostin E2
• Generic Name: Dinoprostone
• Dosage Form: Suppository
• Route of Administration: VAGINAL
• Marketing Start Date: 1978-01-18
• Marketing Category: NDA / NDA
• Application Number: NDA017810
• Labeler Name: Pharmacia and Upjohn Company LLC
• Substance Name: DINOPROSTONE
• Active Ingredient Strength: 20 mg/1
• Pharm Classes: Prostaglandin Analog [EPC],Prostaglandins [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0009-0827-03

5 BLISTER PACK in 1 CARTON (0009-0827-03) > 1 SUPPOSITORY in 1 BLISTER PACK

• Marketing Start Date: 1978-01-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0009-0827-03 [00009082703]

Prostin E2 SUPPOSITORY

• Marketing Category: NDA
• Application Number: NDA017810
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1978-01-18

Drug Details

Active Ingredients

Ingredient	Strength
DINOPROSTONE	20 mg/1

OpenFDA Data

• SPL SET ID: fae013fc-e199-43f3-86ef-66d34017c534
• Manufacturer:
  • Pharmacia and Upjohn Company LLC
• UNII:
  • K7Q1JQR04M
• RxNorm Concept Unique ID - RxCUI:
  • 208407
  • 197619
• PHarm Class EPC:
  • Prostaglandin Analog [EPC]
• UPC Code:
  • 0300090827038
• NUI Code:
  • N0000175454
  • N0000007706

Pharmacological Class

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

NDC Crossover Matching brand name "Prostin E2" or generic name "Dinoprostone"

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