| Product NDC: | 0054-3090 |
| Proprietary Name: | Butorphanol Tartrate |
| Non Proprietary Name: | Butorphanol Tartrate |
| Active Ingredient(s): | 10 mg/mL & nbsp; Butorphanol Tartrate |
| Administration Route(s): | NASAL |
| Dosage Form(s): | SPRAY, METERED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0054-3090 |
| Labeler Name: | Roxane Laboratories, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA075824 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20020312 |
| Package NDC: | 0054-3090-36 |
| Package Description: | 1 BOTTLE, SPRAY in 1 CONTAINER (0054-3090-36) > 15 mL in 1 BOTTLE, SPRAY |
| NDC Code | 0054-3090-36 |
| Proprietary Name | Butorphanol Tartrate |
| Package Description | 1 BOTTLE, SPRAY in 1 CONTAINER (0054-3090-36) > 15 mL in 1 BOTTLE, SPRAY |
| Product NDC | 0054-3090 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Butorphanol Tartrate |
| Dosage Form Name | SPRAY, METERED |
| Route Name | NASAL |
| Start Marketing Date | 20020312 |
| Marketing Category Name | ANDA |
| Labeler Name | Roxane Laboratories, Inc |
| Substance Name | BUTORPHANOL TARTRATE |
| Strength Number | 10 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Competitive Opioid Antagonists [MoA],Opioid Agonist/Antagonist [EPC],Partial Opioid Agonists [MoA] |