Product NDC: | 76478-289 |
Proprietary Name: | EMLA |
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: | 76478-289 |
Labeler Name: | Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA019941 |
Marketing Category: | NDA |
Start Marketing Date: | 20121112 |
Package NDC: | 76478-289-05 |
Package Description: | 1 TUBE in 1 CARTON (76478-289-05) > 5 g in 1 TUBE |
NDC Code | 76478-289-05 |
Proprietary Name | EMLA |
Package Description | 1 TUBE in 1 CARTON (76478-289-05) > 5 g in 1 TUBE |
Product NDC | 76478-289 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | lidocaine and prilocaine |
Dosage Form Name | CREAM |
Route Name | TOPICAL |
Start Marketing Date | 20121112 |
Marketing Category Name | NDA |
Labeler Name | Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) |
Substance Name | LIDOCAINE; PRILOCAINE |
Strength Number | 25; 25 |
Strength Unit | mg/g; mg/g |
Pharmaceutical Classes | Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Local Anesthesia [PE],Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE] |