Regadenoson
- Product NDC
- 71288-201
- 11-digit product format
- 712880201
- Labeler code
- 71288
- Product ID
- 71288-201_347eb6ed-dadc-4127-be90-24f65150fbff
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Regadenoson
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Meitheal Pharmaceuticals Inc.
- Application
- ANDA212806
- Marketing category
- ANDA
- Marketing start
- 2022-04-11
- 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 |
|---|
| 71288-201-85 | Regadenoson | 5 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 5 | | 4 |
| 71288-201-85 | 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 |
|---|
| 71288-201 | REGADENOSON INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.] | 4 | Current NDC, Legacy NDC, 2 package rows | 20220416_a550b451-fb30-4c1c-a60e-6e40fba20c88.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 71288-201-85 | 71288020185 | 1 SYRINGE, PLASTIC in 1 CARTON (71288-201-85) / 5 mL in 1 SYRINGE, PLASTIC | 2022-04-11 | 0000-00-00 | No | No | Current |