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NDC 00338-0355-03 Osmitrol 15 g/100mL Details
Osmitrol 15 g/100mL
Osmitrol is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Baxter Healthcare Corporation. The primary component is MANNITOL.
Product Information
| NDC | 00338-0355 |
|---|---|
| Product ID | 0338-0355_5cb91724-aefd-40ef-8134-b3087e369a78 |
| Associated GPIs | 37400030002015 |
| GCN Sequence Number | 008147 |
| GCN Sequence Number Description | mannitol IV SOLN 15 % INTRAVEN |
| HIC3 | R1B |
| HIC3 Description | OSMOTIC DIURETICS |
| GCN | 34531 |
| HICL Sequence Number | 003635 |
| HICL Sequence Number Description | MANNITOL |
| Brand/Generic | Brand |
| Proprietary Name | Osmitrol |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Mannitol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 15 |
| Active Ingredient Units | g/100mL |
| Substance Name | MANNITOL |
| Labeler Name | Baxter Healthcare Corporation |
| Pharmaceutical Class | Increased Diuresis [PE], Osmotic Activity [MoA], Osmotic Diuretic [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA013684 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00338-0355-03 (00338035503)
| NDC Package Code | 0338-0355-03 |
|---|---|
| Billing NDC | 00338035503 |
| Package | 500 mL in 1 BAG (0338-0355-03) |
| Marketing Start Date | 1964-06-08 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |