Regadenoson
- Product NDC
- 0641-6253
- 11-digit product format
- 006416253
- Labeler code
- 0641
- Product ID
- 0641-6253_6d9e653e-94ea-444c-85cf-f24cbfb74c65
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Regadenoson
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Hikma Pharmaceuticals USA Inc.
- Application
- ANDA215827
- Marketing category
- ANDA
- Marketing start
- 2023-04-03
- Substance
- REGADENOSON ANHYDROUS
- 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 ANHYDROUS | .08 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7AXV542LZ4 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0641-6253-01 | Regadenoson | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 3 |
| 0641-6253-01 | Regadenoson | 5 mL in 1 SYRINGE, PLASTIC | INJECTION, SOLUTION | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0641-6253 | REGADENOSON INJECTION, SOLUTION [HIKMA PHARMACEUTICALS USA INC.] | 3 | Current NDC, 2 package rows | 20240412_9e48b407-1ce3-461d-b48e-de183802de25.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 0641-6253-01 | 00641625301 | 1 SYRINGE, PLASTIC in 1 CARTON (0641-6253-01) / 5 mL in 1 SYRINGE, PLASTIC | 2023-04-03 | No | No | Current |