NDC 0037-8110

MUSE

Alprostadil

MUSE is a Urethral Suppository in the Human Prescription Drug category. It is labeled and distributed by Meda Pharmaceuticals Inc.. The primary component is Alprostadil.

• Product ID: 0037-8110_0209b68d-e74a-43a9-ad21-c9bca0293f0f
• NDC: 0037-8110
• Product Type: Human Prescription Drug
• Proprietary Name: MUSE
• Generic Name: Alprostadil
• Dosage Form: Suppository
• Route of Administration: URETHRAL
• Marketing Start Date: 2011-07-22
• Marketing End Date: 2022-04-30
• Marketing Category: NDA / NDA
• Application Number: NDA020700
• Labeler Name: Meda Pharmaceuticals Inc.
• Substance Name: ALPROSTADIL
• Active Ingredient Strength: 125 ug/1
• 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

Packaging

NDC 0037-8110-06

6 POUCH in 1 CARTON (0037-8110-06) > 1 SUPPOSITORY in 1 POUCH (0037-8110-01)

• Marketing Start Date: 2011-07-22
• Marketing End Date: 2022-03-31
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0037-8110-56 [00037811056]

MUSE SUPPOSITORY

• Marketing Category: NDA
• Application Number: NDA020700
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-07-22

NDC 0037-8110-01 [00037811001]

MUSE SUPPOSITORY

• Marketing Category: NDA
• Application Number: NDA020700
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-07-22

NDC 0037-8110-06 [00037811006]

MUSE SUPPOSITORY

• Marketing Category: NDA
• Application Number: NDA020700
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-07-22

Drug Details

Active Ingredients

Ingredient	Strength
ALPROSTADIL	125 ug/1

OpenFDA Data

• SPL SET ID: 4c55f3f9-c4cf-11df-851a-0800200c9a66
• Manufacturer:
  • Meda Pharmaceuticals
• UNII:
  • F5TD010360
• RxNorm Concept Unique ID - RxCUI:
  • 308054
  • 308051
  • 308052
  • 859130
  • 859132
  • 313829
  • 859128
  • 859126
• 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]

NDC Crossover Matching brand name "MUSE" or generic name "Alprostadil"

NDC	Brand Name	Generic Name
0037-8110	MUSE	Alprostadil
0037-8120	MUSE	Alprostadil
0037-8130	MUSE	Alprostadil
0037-8140	MUSE	Alprostadil
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
0009-0215	PROSTIN	alprostadil
0009-3169	PROSTIN	alprostadil