Regadenoson
- Product NDC
- 43598-616
- 11-digit product format
- 435980616
- Labeler code
- 43598
- Product ID
- 43598-616_4b43c865-fcdb-4e57-30a4-871e37e0e593
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Regadenoson
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Dr. Reddy's Laboratories Inc.
- Application
- ANDA213210
- Marketing category
- ANDA
- Marketing start
- 2023-04-23
- 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 |
|---|
| 43598-616-11 | Regadenoson | 5 mL in 1 CARTON | INJECTION | 5 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43598-616 | REGADENOSON INJECTION [DR. REDDY'S LABORATORIES INC.] | 3 | Current NDC, 1 package rows | 20230519_03ef6420-8190-a404-f7f6-def1864a77de.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 43598-616-11 | 43598061611 | 5 mL in 1 CARTON (43598-616-11) | 5 ml | 2023-04-23 | No | No | Current |