| Product NDC: | 16590-453 |
| Proprietary Name: | PENNSAID |
| Non Proprietary Name: | DICLOFENAC SODIUM |
| Active Ingredient(s): | 16.05 mg/mL & nbsp; DICLOFENAC SODIUM |
| Administration Route(s): | TOPICAL |
| Dosage Form(s): | LIQUID |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 16590-453 |
| Labeler Name: | STAT RX USA LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020947 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20100405 |
| Package NDC: | 16590-453-33 |
| Package Description: | 150 mL in 1 BOTTLE, DROPPER (16590-453-33) |
| NDC Code | 16590-453-33 |
| Proprietary Name | PENNSAID |
| Package Description | 150 mL in 1 BOTTLE, DROPPER (16590-453-33) |
| Product NDC | 16590-453 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | DICLOFENAC SODIUM |
| Dosage Form Name | LIQUID |
| Route Name | TOPICAL |
| Start Marketing Date | 20100405 |
| Marketing Category Name | NDA |
| Labeler Name | STAT RX USA LLC |
| Substance Name | DICLOFENAC SODIUM |
| Strength Number | 16.05 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] |