| Product NDC: | 0517-8880 |
| Proprietary Name: | Sprix |
| Non Proprietary Name: | ketorolac tromethamine |
| Active Ingredient(s): | 15.75 mg/1 & nbsp; ketorolac tromethamine |
| Administration Route(s): | NASAL |
| Dosage Form(s): | SPRAY, METERED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0517-8880 |
| Labeler Name: | American Regent, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA022382 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110426 |
| Package NDC: | 0517-8880-05 |
| Package Description: | 5 BOTTLE, SPRAY in 1 CARTON (0517-8880-05) > 8 SPRAY, METERED in 1 BOTTLE, SPRAY (0517-8880-01) |
| NDC Code | 0517-8880-05 |
| Proprietary Name | Sprix |
| Package Description | 5 BOTTLE, SPRAY in 1 CARTON (0517-8880-05) > 8 SPRAY, METERED in 1 BOTTLE, SPRAY (0517-8880-01) |
| Product NDC | 0517-8880 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | ketorolac tromethamine |
| Dosage Form Name | SPRAY, METERED |
| Route Name | NASAL |
| Start Marketing Date | 20110426 |
| Marketing Category Name | NDA |
| Labeler Name | American Regent, Inc. |
| Substance Name | KETOROLAC TROMETHAMINE |
| Strength Number | 15.75 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC] |