| Product NDC: | 63323-497 |
| Proprietary Name: | Xylocaine |
| Non Proprietary Name: | LIDOCAINE HYDROCHLORIDE |
| Active Ingredient(s): | 40 mg/mL & nbsp; LIDOCAINE HYDROCHLORIDE |
| Administration Route(s): | TOPICAL |
| Dosage Form(s): | SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 63323-497 |
| Labeler Name: | APP Pharmaceuticals, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA010417 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20091111 |
| Package NDC: | 63323-497-50 |
| Package Description: | 1 BOTTLE in 1 BOX (63323-497-50) > 50 mL in 1 BOTTLE |
| NDC Code | 63323-497-50 |
| Proprietary Name | Xylocaine |
| Package Description | 1 BOTTLE in 1 BOX (63323-497-50) > 50 mL in 1 BOTTLE |
| Product NDC | 63323-497 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | LIDOCAINE HYDROCHLORIDE |
| Dosage Form Name | SOLUTION |
| Route Name | TOPICAL |
| Start Marketing Date | 20091111 |
| Marketing Category Name | NDA |
| Labeler Name | APP Pharmaceuticals, LLC |
| Substance Name | LIDOCAINE HYDROCHLORIDE |
| Strength Number | 40 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] |