| Product NDC: | 0054-0045 |
| Proprietary Name: | Ipratropium Bromide |
| Non Proprietary Name: | Ipratropium Bromide |
| Active Ingredient(s): | 21 ug/1 & nbsp; Ipratropium Bromide |
| Administration Route(s): | NASAL |
| Dosage Form(s): | SPRAY |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 0054-0045 |
| Labeler Name: | Roxane Laboratories, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA076664 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20031105 |
| Package NDC: | 0054-0045-44 |
| Package Description: | 1 BOTTLE, SPRAY in 1 CARTON (0054-0045-44) > 345 SPRAY in 1 BOTTLE, SPRAY |
| NDC Code | 0054-0045-44 |
| Proprietary Name | Ipratropium Bromide |
| Package Description | 1 BOTTLE, SPRAY in 1 CARTON (0054-0045-44) > 345 SPRAY in 1 BOTTLE, SPRAY |
| Product NDC | 0054-0045 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Ipratropium Bromide |
| Dosage Form Name | SPRAY |
| Route Name | NASAL |
| Start Marketing Date | 20031105 |
| Marketing Category Name | ANDA |
| Labeler Name | Roxane Laboratories, Inc |
| Substance Name | IPRATROPIUM BROMIDE |
| Strength Number | 21 |
| Strength Unit | ug/1 |
| Pharmaceutical Classes | Anticholinergic [EPC],Cholinergic Antagonists [MoA] |