REGADENOSON
- Product NDC
- 16729-477
- 11-digit product format
- 167290477
- Labeler code
- 16729
- Product ID
- 16729-477_4629312b-729e-9618-e063-6294a90a4c0b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- REGADENOSON
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Accord Healthcare Inc.
- Application
- ANDA213236
- Marketing category
- ANDA
- Marketing start
- 2023-03-10
- 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
- REGADENOSON
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| REGADENOSON | .08 mg/mL |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 16729-477-31 | 16729047731 | 5 mL in 1 SYRINGE, GLASS (16729-477-31) | 5 ml | 2023-03-10 | No | No | Current |