| Product NDC: | 0168-0803 |
| Proprietary Name: | DICLOFENAC SODIUM |
| Non Proprietary Name: | diclofenac sodium |
| Active Ingredient(s): | 30 mg/g & nbsp; diclofenac sodium |
| Administration Route(s): | TOPICAL |
| Dosage Form(s): | GEL |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0168-0803 |
| Labeler Name: | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021005 |
| Marketing Category: | NDA AUTHORIZED GENERIC |
| Start Marketing Date: | 20130506 |
| Package NDC: | 0168-0803-01 |
| Package Description: | 1 TUBE in 1 CARTON (0168-0803-01) > 100 g in 1 TUBE |
| NDC Code | 0168-0803-01 |
| Proprietary Name | DICLOFENAC SODIUM |
| Package Description | 1 TUBE in 1 CARTON (0168-0803-01) > 100 g in 1 TUBE |
| Product NDC | 0168-0803 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | diclofenac sodium |
| Dosage Form Name | GEL |
| Route Name | TOPICAL |
| Start Marketing Date | 20130506 |
| Marketing Category Name | NDA AUTHORIZED GENERIC |
| Labeler Name | E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. |
| Substance Name | DICLOFENAC SODIUM |
| Strength Number | 30 |
| Strength Unit | mg/g |
| Pharmaceutical Classes | Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] |