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NDC 16729-0477-31 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 Accord Healthcare Inc.. The primary component is REGADENOSON.
Product Information
| NDC | 16729-0477 |
|---|---|
| Product ID | 16729-477_f6cacd68-0f58-deb9-e053-6294a90aa266 |
| 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 |
| Labeler Name | Accord Healthcare Inc. |
| Pharmaceutical Class | Adenosine Receptor Agonists [MoA], Pharmacologic Cardiac Stress Test Agent [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA213236 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 16729-0477-31 (16729047731)
| NDC Package Code | 16729-477-31 |
|---|---|
| Billing NDC | 16729047731 |
| Package | 5 mL in 1 SYRINGE, GLASS (16729-477-31) |
| Marketing Start Date | 2023-03-10 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |