regadenoson
- Product NDC
- 55150-443
- 11-digit product format
- 551500443
- Labeler code
- 55150
- Product ID
- 55150-443_c82d9c48-e9fd-489b-a9f3-7a28f42d0a1e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- regadenoson
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Eugia US LLC
- Application
- ANDA216437
- Marketing category
- ANDA
- Marketing start
- 2022-10-26
- 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
- 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 |
|---|
| 55150-443-01 | regadenoson | 1 in 1 CARTON | INJECTION | 1 | | 3 |
| 55150-443-01 | 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 |
|---|
| 55150-443 | REGADENOSON INJECTION [EUGIA US LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20231219_b553eb2d-0c3f-444e-ad4c-282328683110.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 55150-443-01 | 55150044301 | 1 SYRINGE in 1 CARTON (55150-443-01) / 5 mL in 1 SYRINGE | 1 syringe | 2022-10-26 | 0000-00-00 | No | No | Current |