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NDC 63323-0468-17 SENSORCAINE 2.5; .005 mg/mL; mg/mL Details
SENSORCAINE 2.5; .005 mg/mL; mg/mL
SENSORCAINE is a EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE.
Product Information
| NDC | 63323-0468 |
|---|---|
| Product ID | 63323-468_cc1f6507-eb3e-4398-a1d3-0c56a2099e6b |
| Associated GPIs | 69991002102012 |
| GCN Sequence Number | 052187 |
| GCN Sequence Number Description | bupivacaine HCl/epinephrine/PF VIAL 0.25-.0005 INJECTION |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 19750 |
| HICL Sequence Number | 025242 |
| HICL Sequence Number Description | BUPIVACAINE HCL/EPINEPHRINE/PF |
| Brand/Generic | Brand |
| Proprietary Name | SENSORCAINE |
| Proprietary Name Suffix | MPF |
| Non-Proprietary Name | BUPIVACAINE HYDROCHLORIDE and EPINEPHRINE BITARTRATE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
| Active Ingredient Strength | 2.5; .005 |
| Active Ingredient Units | mg/mL; mg/mL |
| Substance Name | BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE |
| Labeler Name | Fresenius Kabi USA, LLC |
| 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 | ANDA070966 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0468-17 (63323046817)
| NDC Package Code | 63323-468-17 |
|---|---|
| Billing NDC | 63323046817 |
| Package | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-468-17) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-468-01) |
| Marketing Start Date | 2010-11-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |