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NDC 00362-9011-50 Vivacaine 5; .005 mg/mL; mg/mL Details
Vivacaine 5; .005 mg/mL; mg/mL
Vivacaine is a SUBCUTANEOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Septodont, Inc.. The primary component is BUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE.
Product Information
| NDC | 00362-9011 |
|---|---|
| Product ID | 0362-9011_79e3c6ef-9762-4afd-ace6-d6214d6a9c77 |
| Associated GPIs | |
| GCN Sequence Number | 043048 |
| GCN Sequence Number Description | bupivacaine HCl/epinephrine bi CARTRIDGE 0.5-1:200K INJECTION |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 92864 |
| HICL Sequence Number | 013744 |
| HICL Sequence Number Description | BUPIVACAINE HCL/EPINEPHRINE BITARTRATE |
| Brand/Generic | Generic |
| Proprietary Name | Vivacaine |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | bupivacaine hydrochloride and epinephrine bitartrate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 5; .005 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | BUPIVACAINE HYDROCHLORIDE ANHYDROUS; EPINEPHRINE BITARTRATE |
| Labeler Name | Septodont, Inc. |
| Pharmaceutical Class | Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Catecholamine [EPC], Catecholamines [CS], Local Anesthesia [PE], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA077250 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00362-9011-50 (00362901150)
| NDC Package Code | 0362-9011-50 |
|---|---|
| Billing NDC | 00362901150 |
| Package | 50 CARTRIDGE in 1 CARTON (0362-9011-50) / 1.8 mL in 1 CARTRIDGE |
| Marketing Start Date | 2013-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |