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NDC 63323-0024-25 Mannitol 250 mg/mL Details
Mannitol 250 mg/mL
Mannitol is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fresenius Kabi USA, LLC. The primary component is MANNITOL.
Product Information
| NDC | 63323-0024 |
|---|---|
| Product ID | 63323-024_fe8beed4-a8db-400e-834e-b5efe2f5af1c |
| Associated GPIs | 37400030002025 |
| GCN Sequence Number | 008151 |
| GCN Sequence Number Description | mannitol VIAL 25 % INTRAVEN |
| HIC3 | R1B |
| HIC3 Description | OSMOTIC DIURETICS |
| GCN | 34551 |
| HICL Sequence Number | 003635 |
| HICL Sequence Number Description | MANNITOL |
| Brand/Generic | Generic |
| Proprietary Name | Mannitol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | MANNITOL |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 250 |
| Active Ingredient Units | mg/mL |
| Substance Name | MANNITOL |
| Labeler Name | Fresenius Kabi USA, LLC |
| Pharmaceutical Class | Increased Diuresis [PE], Osmotic Activity [MoA], Osmotic Diuretic [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA080677 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63323-0024-25 (63323002425)
| NDC Package Code | 63323-024-25 |
|---|---|
| Billing NDC | 63323002425 |
| Package | 25 VIAL, SINGLE-DOSE in 1 TRAY (63323-024-25) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-024-01) |
| Marketing Start Date | 2000-03-19 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |