Treprostinil
- Product NDC
- 62332-514
- 11-digit product format
- 623320514
- Labeler code
- 62332
- Product ID
- 62332-514_5384ef7c-88cc-4ab7-8eb7-627eba752f9d
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Treprostinil
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS; SUBCUTANEOUS
- Labeler
- Alembic Pharmaceuticals Inc.
- Application
- ANDA211574
- Marketing category
- ANDA
- Marketing start
- 2021-02-11
- Substance
- TREPROSTINIL
- Active strength
- 20 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 | 20 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 |
|---|
| 62332-514-20 | Treprostinil | 20 mL in 1 VIAL | INJECTION, SOLUTION | 20 | | 8 |
| 62332-514-20 | Treprostinil | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62332-514 | TREPROSTINIL INJECTION, SOLUTION [ALEMBIC PHARMACEUTICALS INC.] | 8 | Current NDC, Legacy NDC, 2 package rows | 20250313_4a684b13-669d-4721-8ed4-30cc7762b0b8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 62332-514-20 | 62332051420 | 1 VIAL in 1 CARTON (62332-514-20) / 20 mL in 1 VIAL | 1 vial | 2021-02-11 | 0000-00-00 | No | No | Current |