Orenitram
- Product NDC
- 66302-363
- 11-digit product format
- 663020363
- Labeler code
- 66302
- Product ID
- 66302-363_bd66c62e-4aee-4fd0-bc7d-f78994dd9e29
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- treprostinil
- Dosage form
- KIT
- Labeler
- United Therapeutics Corporation
- Application
- NDA203496
- Marketing category
- NDA
- Marketing start
- 2023-02-14
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| RUM6K67ESG | TREPROSTINIL | 81846-19-7 | treprostinil |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 66302-363-84 | 66302036384 | 1 KIT in 1 PACKAGE (66302-363-84) * 42 TABLET, EXTENDED RELEASE in 1 BLISTER PACK * 84 TABLET, EXTENDED RELEASE in 1 BLISTER PACK * 126 TABLET, EXTENDED RELEASE in 1 BLISTER PACK | 1 kit | 2023-02-14 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Orenitram | United Therapeutics Corporation | 2024-11-20 | HUMAN PRESCRIPTION DRUG LABEL | 24 |