| Product NDC: | 0168-0357 |
| Proprietary Name: | Lidocaine and Prilocaine |
| Non Proprietary Name: | lidocaine and prilocaine |
| Active Ingredient(s): | 25; 25 mg/g; mg/g & nbsp; lidocaine and prilocaine |
| Administration Route(s): | TOPICAL |
| Dosage Form(s): | CREAM |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0168-0357 |
| Labeler Name: | E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076453 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20030818 |
| Package NDC: | 0168-0357-55 |
| Package Description: | 1 TUBE in 1 CARTON (0168-0357-55) > 5 g in 1 TUBE (0168-0357-05) |
| NDC Code | 0168-0357-55 |
| Proprietary Name | Lidocaine and Prilocaine |
| Package Description | 1 TUBE in 1 CARTON (0168-0357-55) > 5 g in 1 TUBE (0168-0357-05) |
| Product NDC | 0168-0357 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | lidocaine and prilocaine |
| Dosage Form Name | CREAM |
| Route Name | TOPICAL |
| Start Marketing Date | 20030818 |
| Marketing Category Name | ANDA |
| Labeler Name | E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. |
| 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] |