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NDC 00641-6253-01 Regadenoson 0.08 mg/mL Details
Regadenoson 0.08 mg/mL
Regadenoson is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Hikma Pharmaceuticals USA Inc.. The primary component is REGADENOSON ANHYDROUS.
Product Information
| NDC | 00641-6253 |
|---|---|
| Product ID | 0641-6253_0f68f5ee-f4c5-4306-b779-5d283742807d |
| Associated GPIs | |
| GCN Sequence Number | 064044 |
| GCN Sequence Number Description | regadenoson SYRINGE 0.4 MG/5ML INTRAVEN |
| HIC3 | A6V |
| HIC3 Description | CARDIOVASCULAR DIAGNOSTICS,NON-RADIOPAQUE AGENTS |
| GCN | 99755 |
| HICL Sequence Number | 035625 |
| HICL Sequence Number Description | REGADENOSON |
| Brand/Generic | Generic |
| Proprietary Name | Regadenoson |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Regadenoson |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 0.08 |
| Active Ingredient Units | mg/mL |
| Substance Name | REGADENOSON ANHYDROUS |
| Labeler Name | Hikma Pharmaceuticals USA Inc. |
| Pharmaceutical Class | Adenosine Receptor Agonists [MoA], Pharmacologic Cardiac Stress Test Agent [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA215827 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00641-6253-01 (00641625301)
| NDC Package Code | 0641-6253-01 |
|---|---|
| Billing NDC | 00641625301 |
| Package | 1 SYRINGE, PLASTIC in 1 CARTON (0641-6253-01) / 5 mL in 1 SYRINGE, PLASTIC |
| Marketing Start Date | 2023-04-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |