| Product NDC: | 63323-289 |
| Proprietary Name: | EMLA |
| Non Proprietary Name: | LIDOCAINE |
| Active Ingredient(s): | 25; 25 mg/g; mg/g & nbsp; LIDOCAINE |
| Administration Route(s): | TOPICAL |
| Dosage Form(s): | CREAM |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 63323-289 |
| Labeler Name: | APP Pharmaceuticals, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA019941 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20090929 |
| Package NDC: | 63323-289-55 |
| Package Description: | 5 TUBE in 1 BOX (63323-289-55) > 5 g in 1 TUBE |
| NDC Code | 63323-289-55 |
| Proprietary Name | EMLA |
| Package Description | 5 TUBE in 1 BOX (63323-289-55) > 5 g in 1 TUBE |
| Product NDC | 63323-289 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | LIDOCAINE |
| Dosage Form Name | CREAM |
| Route Name | TOPICAL |
| Start Marketing Date | 20090929 |
| Marketing Category Name | NDA |
| Labeler Name | APP Pharmaceuticals, LLC |
| Substance Name | LIDOCAINE; PRILOCAINE |
| Strength Number | 25; 25 |
| Strength Unit | mg/g; mg/g |
| Pharmaceutical Classes | Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE] |