NDC 0781-3427

Treprostinil

Treprostinil

Treprostinil is a Intravenous; Subcutaneous Injection in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Treprostinil.

• Product ID: 0781-3427_19f50f18-7400-4b9f-b97a-49b16c48b207
• NDC: 0781-3427
• Product Type: Human Prescription Drug
• Proprietary Name: Treprostinil
• Generic Name: Treprostinil
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS; SUBCUTANEOUS
• Marketing Start Date: 2019-03-25
• Marketing Category: ANDA / ANDA
• Application Number: ANDA203649
• Labeler Name: Sandoz Inc
• 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: 2021-12-31

Packaging

NDC 0781-3427-80

1 VIAL, MULTI-DOSE in 1 CARTON (0781-3427-80) > 20 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2019-03-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0781-3427-80 [00781342780]

Treprostinil INJECTION

• Marketing Category: ANDA
• Application Number: ANDA203649
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-03-25

Drug Details

Active Ingredients

Ingredient	Strength
TREPROSTINIL	100 mg/20mL

OpenFDA Data

• SPL SET ID: 473297ca-a872-4052-a053-87dc8f0d3c13
• Manufacturer:
  • Sandoz Inc
• UNII:
  • 059QF0KO0R
  • RUM6K67ESG
• RxNorm Concept Unique ID - RxCUI:
  • 349408
  • 349409
  • 349410
  • 349407

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
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
66302-101	Remodulin	treprostinil
66302-102	Remodulin	treprostinil