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NDC 63323-0493-97 Xylocaine 15 mg/mL Details
Xylocaine 15 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 | 63323-0493 |
|---|---|
| Product ID | 63323-493_bf0e6f28-00fc-4b40-a5b2-3ddaa5048dda |
| Associated GPIs | 69100040102016 |
| GCN Sequence Number | 060670 |
| GCN Sequence Number Description | lidocaine HCl/PF AMPUL 15 MG/ML INJECTION |
| HIC3 | H0A |
| HIC3 Description | LOCAL ANESTHETICS |
| GCN | 26877 |
| 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 | 15 |
| 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 63323-0493-97 (63323049397)
| NDC Package Code | 63323-493-97 |
|---|---|
| Billing NDC | 63323049397 |
| Package | 5 AMPULE in 1 BOX (63323-493-97) / 10 mL in 1 AMPULE (63323-493-03) |
| Marketing Start Date | 2011-07-18 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |