NDC 66302-105

Remodulin

Treprostinil

Remodulin is a Intravenous; Subcutaneous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by United Therapeutics Corporation. The primary component is Treprostinil.

• Product ID: 66302-105_14e0bedf-b5f3-45a5-9de5-863ddb53e7b9
• NDC: 66302-105
• Product Type: Human Prescription Drug
• Proprietary Name: Remodulin
• Generic Name: Treprostinil
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 2002-05-22
• Marketing Category: NDA / NDA
• Application Number: NDA021272
• Labeler Name: United Therapeutics Corporation
• Substance Name: TREPROSTINIL
• Active Ingredient Strength: 100 mg/20mL
• Pharm Classes: Prostacycline Vasodilator [EPC],Prostaglandins I [CS],Vasodilation [PE]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 66302-105-01

1 VIAL in 1 BOX (66302-105-01) > 20 mL in 1 VIAL

• Marketing Start Date: 2002-05-22
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66302-105-01 [66302010501]

Remodulin INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA021272
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2002-05-22

Drug Details

Active Ingredients

Ingredient	Strength
TREPROSTINIL	100 mg/20mL

OpenFDA Data

• SPL SET ID: 6c80bb38-e8db-4138-9f0d-dbbf9c673185
• Manufacturer:
  • United Therapeutics Corporation
• UNII:
  • 059QF0KO0R
  • RUM6K67ESG
• RxNorm Concept Unique ID - RxCUI:
  • 352214
  • 349410
  • 540930
  • 349408
  • 349409
  • 352211
  • 352213
  • 352212
  • 349407

Pharmacological Class

• Prostacycline Vasodilator [EPC]
• Prostaglandins I [CS]
• Vasodilation [PE]

NDC Crossover Matching brand name "Remodulin" or generic name "Treprostinil"

NDC	Brand Name	Generic Name
66302-101	Remodulin	treprostinil
66302-102	Remodulin	treprostinil
66302-105	Remodulin	Remodulin
66302-110	Remodulin	Remodulin
0703-0666	Treprostinil	Treprostinil
0703-0676	Treprostinil	Treprostinil
0703-0686	Treprostinil	Treprostinil
0703-0696	Treprostinil	Treprostinil
0781-3420	Treprostinil	treprostinil
0781-3425	Treprostinil	treprostinil
0781-3427	Treprostinil	treprostinil
0781-3430	Treprostinil	treprostinil
42023-206	Treprostinil	Treprostinil
42023-207	Treprostinil	Treprostinil
42023-208	Treprostinil	Treprostinil
42023-209	Treprostinil	Treprostinil
62332-514	Treprostinil	Treprostinil
62332-515	Treprostinil	Treprostinil
62332-516	Treprostinil	Treprostinil
62332-517	Treprostinil	Treprostinil