LEXISCAN(R) (REGADENOSON)
- Product NDC
- 51662-1448
- 11-digit product format
- 516621448
- Labeler code
- 51662
- Product ID
- 51662-1448_0ffbfae4-66b6-b616-e063-6294a90a2d06
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LEXISCAN(R) (REGADENOSON)
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- HF Acquisition Co LLC, DBA HealthFirst
- Application
- NDA022161
- Marketing category
- NDA
- Marketing start
- 2019-12-10
- Substance
- REGADENOSON
- Active strength
- .08 mg/mL
- Pharmacologic classes
- Adenosine Receptor Agonists [MoA], Pharmacologic Cardiac Stress Test Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LEXISCAN(R) (REGADENOSON)
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| REGADENOSON | .08 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2XLN4Y044H |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51662-1448-1 | LEXISCAN(R) (REGADENOSON) | 5 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 5 | | 4 |
| 51662-1448-1 | LEXISCAN(R) (REGADENOSON) | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51662-1448 | LEXISCAN(R) (REGADENOSON) INJECTION, SOLUTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] | 4 | Current NDC, Legacy NDC, 2 package rows | 20240129_99640071-4db2-9317-e053-2995a90a610d.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 51662-1448-1 | 51662144801 | 1 SYRINGE, PLASTIC in 1 CARTON (51662-1448-1) / 5 mL in 1 SYRINGE, PLASTIC | 2019-12-10 | 0000-00-00 | No | No | Current |