NDC 0009-3169

PROSTIN VR PEDIATRIC

Alprostadil

PROSTIN VR PEDIATRIC is a Intravascular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmacia And Upjohn Company Llc. The primary component is Alprostadil.

• Product ID: 0009-3169_b352eb18-5983-473a-a627-0271ef2ba4cf
• NDC: 0009-3169
• Product Type: Human Prescription Drug
• Proprietary Name: PROSTIN VR PEDIATRIC
• Generic Name: Alprostadil
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVASCULAR; INTRAVENOUS
• Marketing Start Date: 1981-10-16
• Marketing Category: NDA / NDA
• Application Number: NDA018484
• Labeler Name: Pharmacia and Upjohn Company LLC
• Substance Name: ALPROSTADIL
• Active Ingredient Strength: 500 ug/mL
• Pharm Classes: Genitourinary Arterial Vasodilation [PE],Prostaglandin Analog [EPC],Prostaglandin E1 Agonist [EPC],Prostaglandin Receptor Agonists [MoA],Prostaglandins [CS],Venous Vasodilation [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0009-3169-06

5 AMPULE in 1 PACKAGE (0009-3169-06) > 1 mL in 1 AMPULE (0009-3169-01)

• Marketing Start Date: 1981-10-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0009-3169-01 [00009316901]

PROSTIN INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA018484
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1981-10-16

NDC 0009-3169-06 [00009316906]

PROSTIN INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA018484
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1981-10-16

Drug Details

Active Ingredients

Ingredient	Strength
ALPROSTADIL	500 ug/mL

OpenFDA Data

• SPL SET ID: dea460fa-d05e-4191-8461-f185a711ad89
• Manufacturer:
  • Pharmacia and Upjohn Company LLC
• UNII:
  • F5TD010360
• RxNorm Concept Unique ID - RxCUI:
  • 237212
  • 105467
• Pharm Class PE:
  • Genitourinary Arterial Vasodilation [PE]
  • Venous Vasodilation [PE]
• PHarm Class EPC:
  • Prostaglandin Analog [EPC]
  • Prostaglandin E1 Agonist [EPC]
• NUI Code:
  • N0000009059
  • N0000000106
  • N0000175454
  • N0000007706
  • N0000009911
  • N0000180189

Pharmacological Class

• Genitourinary Arterial Vasodilation [PE]
• Prostaglandin Analog [EPC]
• Prostaglandin E1 Agonist [EPC]
• Prostaglandin Receptor Agonists [MoA]
• Prostaglandins [Chemical/Ingredient]
• Venous Vasodilation [PE]
• Prostaglandins [CS]
• Genitourinary Arterial Vasodilation [PE]
• Prostaglandin Analog [EPC]
• Prostaglandin E1 Agonist [EPC]
• Prostaglandin Receptor Agonists [MoA]
• Prostaglandins [CS]
• Venous Vasodilation [PE]

NDC Crossover Matching brand name "PROSTIN VR PEDIATRIC" or generic name "Alprostadil"

NDC	Brand Name	Generic Name
0703-1501	Alprostadil	Alprostadil
0009-3701	Caverject	Alprostadil
0009-7686	Caverject	Alprostadil
0009-5181	Caverject Impulse	Alprostadil
0009-5182	Caverject Impulse	Alprostadil
63539-121	Caverject Impulse	Alprostadil
63539-221	Caverject Impulse	Alprostadil
52244-010	Edex	alprostadil
52244-020	Edex	alprostadil
52244-040	Edex	alprostadil
0037-8110	MUSE	Alprostadil
0037-8120	MUSE	Alprostadil
0037-8130	MUSE	Alprostadil
0037-8140	MUSE	Alprostadil
0009-0215	PROSTIN	alprostadil
0009-3169	PROSTIN	alprostadil