| Product NDC: | 52584-031 |
| Proprietary Name: | Mannitol |
| Non Proprietary Name: | Mannitol |
| Active Ingredient(s): | 250 mg/mL & nbsp; Mannitol |
| Administration Route(s): | INTRAVENOUS |
| Dosage Form(s): | INJECTION, SOLUTION |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 52584-031 |
| Labeler Name: | General Injectables & Vaccines, Inc |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA016269 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20100801 |
| Package NDC: | 52584-031-01 |
| Package Description: | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-031-01) > 50 mL in 1 VIAL, SINGLE-DOSE |
| NDC Code | 52584-031-01 |
| Proprietary Name | Mannitol |
| Package Description | 1 VIAL, SINGLE-DOSE in 1 BAG (52584-031-01) > 50 mL in 1 VIAL, SINGLE-DOSE |
| Product NDC | 52584-031 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | Mannitol |
| Dosage Form Name | INJECTION, SOLUTION |
| Route Name | INTRAVENOUS |
| Start Marketing Date | 20100801 |
| Marketing Category Name | ANDA |
| Labeler Name | General Injectables & Vaccines, Inc |
| Substance Name | MANNITOL |
| Strength Number | 250 |
| Strength Unit | mg/mL |
| Pharmaceutical Classes | Increased Diuresis [PE],Osmotic Activity [MoA],Osmotic Diuretic [EPC] |