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NDC 63323-0492-57 Xylocaine 10 mg/mL Details
Xylocaine 10 mg/mL
Xylocaine 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 LIDOCAINE HYDROCHLORIDE ANHYDROUS.
Product Information
| NDC | 63323-0492 |
|---|---|
| Product ID | 63323-492_bf0e6f28-00fc-4b40-a5b2-3ddaa5048dda |
| Associated GPIs | 69100040102011 |
| GCN Sequence Number | 060675 |
| GCN Sequence Number Description | lidocaine HCl/PF VIAL 10 MG/ML INJECTION |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 26886 |
| HICL Sequence Number | 033592 |
| HICL Sequence Number Description | LIDOCAINE HCL/PF |
| Brand/Generic | Brand |
| Proprietary Name | Xylocaine |
| Proprietary Name Suffix | MPF |
| Non-Proprietary Name | LIDOCAINE HYDROCHLORIDE |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/mL |
| Substance Name | LIDOCAINE HYDROCHLORIDE ANHYDROUS |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA006488 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0492-57 (63323049257)
| NDC Package Code | 63323-492-57 |
|---|---|
| Billing NDC | 63323049257 |
| Package | 25 VIAL, SINGLE-DOSE in 1 CARTON (63323-492-57) / 5 mL in 1 VIAL, SINGLE-DOSE (63323-492-09) |
| Marketing Start Date | 2010-08-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |