| Product NDC: | 63323-877 |
| Proprietary Name: | NebuPent |
| Non Proprietary Name: | PENTAMIDINE ISETHIONATE |
| Active Ingredient(s): | 300 mg/6mL & nbsp; PENTAMIDINE ISETHIONATE |
| Administration Route(s): | RESPIRATORY (INHALATION) |
| Dosage Form(s): | INHALANT |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 63323-877 |
| Labeler Name: | APP Pharmaceuticals, LLC |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA019887 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110215 |
| Package NDC: | 63323-877-15 |
| Package Description: | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-877-15) > 6 mL in 1 VIAL, SINGLE-DOSE |
| NDC Code | 63323-877-15 |
| Proprietary Name | NebuPent |
| Package Description | 1 VIAL, SINGLE-DOSE in 1 CARTON (63323-877-15) > 6 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 63323-877 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | PENTAMIDINE ISETHIONATE |
| Dosage Form Name | INHALANT |
| Route Name | RESPIRATORY (INHALATION) |
| Start Marketing Date | 20110215 |
| Marketing Category Name | NDA |
| Labeler Name | APP Pharmaceuticals, LLC |
| Substance Name | PENTAMIDINE ISETHIONATE |
| Strength Number | 300 |
| Strength Unit | mg/6mL |
| Pharmaceutical Classes | Antiprotozoal [EPC] |