NDC 63539-121

Caverject Impulse

Alprostadil

Caverject Impulse is a Intracavernous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by U.s. Pharmaceuticals. The primary component is Alprostadil.

• Product ID: 63539-121_0dcd3231-552e-4243-bbc9-b8ed733d3ff4
• NDC: 63539-121
• Product Type: Human Prescription Drug
• Proprietary Name: Caverject Impulse
• Generic Name: Alprostadil
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRACAVERNOUS
• Marketing Start Date: 2014-05-04
• Marketing Category: NDA / NDA
• Application Number: NDA021212
• Labeler Name: U.S. Pharmaceuticals
• Substance Name: ALPROSTADIL
• Active Ingredient Strength: 10 ug/.5mL
• 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: 2020-12-31

Packaging

NDC 63539-121-11

2 SYRINGE in 1 CARTON (63539-121-11) > .5 mL in 1 SYRINGE (63539-121-10)

• Marketing Start Date: 2014-05-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63539-121-11 [63539012111]

Caverject Impulse INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021212
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-05-04

NDC 63539-121-10 [63539012110]

Caverject Impulse INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA021212
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2014-05-04

Drug Details

Active Ingredients

Ingredient	Strength
ALPROSTADIL	10 ug/.5mL

OpenFDA Data

• SPL SET ID: d8f85a7e-becb-4e15-9829-40e8f359140a
• Manufacturer:
  • U.S. Pharmaceuticals
• UNII:
  • F5TD010360
• RxNorm Concept Unique ID - RxCUI:
  • 763474
  • 763470
  • 763473
  • 763472
• 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 "Caverject Impulse" or generic name "Alprostadil"

NDC	Brand Name	Generic Name
0009-5181	Caverject Impulse	Alprostadil
0009-5182	Caverject Impulse	Alprostadil
63539-121	Caverject Impulse	Alprostadil
63539-221	Caverject Impulse	Alprostadil
0703-1501	Alprostadil	Alprostadil
0009-3701	Caverject	Alprostadil
0009-7686	Caverject	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