Regadenoson
- Product NDC
- 76329-3321
- 11-digit product format
- 763293321
- Labeler code
- 76329
- Product ID
- 76329-3321_350f0b8b-7ae6-4b31-8aa3-2178f5c869d7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Regadenoson
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- International Medication Systems, Limited
- Application
- ANDA214252
- Marketing category
- ANDA
- Marketing start
- 2023-04-20
- 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 |
|---|
| 76329-3321-0 | Regadenoson | 5 mL in 1 SYRINGE | INJECTION, SOLUTION | 5 | | 4 |
| 76329-3321-0 | 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 |
|---|
| 76329-3321 | REGADENOSON INJECTION, SOLUTION [INTERNATIONAL MEDICATION SYSTEMS, LIMITED] | 4 | Current NDC, 2 package rows | 20230421_288c76cc-ff3e-47ea-ae02-be566bd3e093.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 76329-3321-0 | 76329332100 | 1 SYRINGE in 1 CARTON (76329-3321-0) / 5 mL in 1 SYRINGE | 1 syringe | 2023-04-20 | No | No | Current |