Regadenoson
- Product NDC
- 10135-803
- 11-digit product format
- 101350803
- Labeler code
- 10135
- Product ID
- 10135-803_b35f97f9-3052-4431-893e-ec9218aab105
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Regadenoson
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Marlex Pharmaceuticals, Inc.
- Application
- ANDA218054
- Marketing category
- ANDA
- Marketing start
- 2024-08-22
- 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 |
|---|
| 10135-803-51 | Regadenoson | 5 mL in 1 SYRINGE | INJECTION, SOLUTION | 5 | | 1 |
| 10135-803-51 | Regadenoson | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 10135-803-51 | 10135080351 | 1 SYRINGE in 1 CARTON (10135-803-51) / 5 mL in 1 SYRINGE | 1 syringe | 2024-08-22 | No | No | Current |