NDC 0703-1501

Alprostadil

Alprostadil

Alprostadil is a Intravascular Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Teva Parenteral Medicines, Inc.. The primary component is Alprostadil.

• Product ID: 0703-1501_1d167a27-0a2a-47e4-bc45-b5c137cbec07
• NDC: 0703-1501
• Product Type: Human Prescription Drug
• Proprietary Name: Alprostadil
• Generic Name: Alprostadil
• Dosage Form: Injection, Solution, Concentrate
• Route of Administration: INTRAVASCULAR
• Marketing Start Date: 1999-04-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA075196
• Labeler Name: Teva Parenteral Medicines, Inc.
• 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 0703-1501-02

5 VIAL, SINGLE-USE in 1 CARTON (0703-1501-02) > 1 mL in 1 VIAL, SINGLE-USE (0703-1501-01)

• Marketing Start Date: 1999-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0703-1501-02 [00703150102]

Alprostadil INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: ANDA
• Application Number: ANDA075196
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1999-04-30

NDC 0703-1501-01 [00703150101]

Alprostadil INJECTION, SOLUTION, CONCENTRATE

• Marketing Category: ANDA
• Application Number: ANDA075196
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 1999-04-30

Drug Details

Active Ingredients

Ingredient	Strength
ALPROSTADIL	500 ug/mL

OpenFDA Data

• SPL SET ID: bb155759-3889-4cb3-9695-42a588f4f689
• Manufacturer:
  • Teva Parenteral Medicines, Inc.
• UNII:
  • F5TD010360
• RxNorm Concept Unique ID - RxCUI:
  • 237212
• 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 "Alprostadil" 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