Treprostinil is a Intravenous; Subcutaneous Solution in the Human Prescription Drug category. It is labeled and distributed by Teva Parenteral Medicines, Inc.. The primary component is Treprostinil.
| Product ID | 0703-0686_27fb2f4e-0d20-47b0-b838-2a113465104c |
| NDC | 0703-0686 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Treprostinil |
| Generic Name | Treprostinil |
| Dosage Form | Solution |
| Route of Administration | INTRAVENOUS; SUBCUTANEOUS |
| Marketing Start Date | 2019-09-30 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA206648 |
| Labeler Name | Teva Parenteral Medicines, 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 | 2020-12-31 |
| Marketing Start Date | 2019-09-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
| Marketing Category | ANDA |
| Application Number | ANDA206648 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2019-09-30 |
| Ingredient | Strength |
|---|---|
| TREPROSTINIL | 100 mg/20mL |
| 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 |