Treprostinil
- Product NDC
- 0703-0676
- 11-digit product format
- 007030676
- Labeler code
- 0703
- Product ID
- 0703-0676_c7be0baa-694d-498d-a474-3611f7773954
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Treprostinil
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Teva Parenteral Medicines, Inc.
- Application
- ANDA206648
- Marketing category
- ANDA
- Marketing start
- 2019-09-30
- Substance
- TREPROSTINIL
- Active strength
- 50 mg/20mL
- Pharmacologic classes
- Prostacycline Vasodilator [EPC], Prostaglandins I [CS], Vasodilation [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Treprostinil
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TREPROSTINIL | 50 mg/20mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RUM6K67ESG |
| Rxcui | 349407, 349408, 349409, 349410 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0703-0676-01 | Treprostinil | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 5 |
| 0703-0676-01 | Treprostinil | 20 mL in 1 VIAL, MULTI-DOSE | INJECTION, SOLUTION | 20 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0703-0676 | TREPROSTINIL INJECTION, SOLUTION [TEVA PARENTERAL MEDICINES, INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20220624_4b2ce4aa-4302-49db-9456-c8cf0e034968.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0703-0676-01 | 00703067601 | 1 VIAL, MULTI-DOSE in 1 CARTON (0703-0676-01) / 20 mL in 1 VIAL, MULTI-DOSE | 2019-09-30 | 0000-00-00 | No | No | Current |