Regadenoson
- Product NDC
- 67457-994
- 11-digit product format
- 674570994
- Labeler code
- 67457
- Product ID
- 67457-994_e6bccf18-bc12-4f68-a021-af21b5026e16
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Regadenoson
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Mylan Institutional LLC
- Application
- ANDA213856
- Marketing category
- ANDA
- Marketing start
- 2023-09-21
- Marketing end
- 2026-06-30
- Substance
- REGADENOSON
- Active strength
- .4 mg/5mL
- Pharmacologic classes
- Adenosine Receptor Agonists [MoA], Pharmacologic Cardiac Stress Test Agent [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Regadenoson
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| REGADENOSON | .4 mg/5mL |
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 |
|---|
| 67457-994-05 | Regadenoson | 1 in 1 CARTON | INJECTION | 1 | | 3 |
| 67457-994-05 | Regadenoson | 5 mL in 1 SYRINGE | INJECTION | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 67457-994 | REGADENOSON INJECTION [MYLAN INSTITUTIONAL LLC] | 3 | Current NDC, 2 package rows | 20241215_e1ab38bf-cfd0-444f-a8a6-bb8588b63228.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 67457-994-05 | 67457099405 | 1 SYRINGE in 1 CARTON (67457-994-05) / 5 mL in 1 SYRINGE | 1 syringe | 2023-09-21 | 2026-06-30 | No | No | Historical |