Prescription drug · NDA
Mannitol NDC 0404-9905
Mannitol 12.5 g/50mL · Injection, Solution · Intravenous · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9905-50 | 00404990550 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9905-50) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 12, 2022 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Mannitol
- Generic name (nonproprietary)
- mannitol
- Active ingredients
- Mannitol — 12.5 g/50mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Henry Schein, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 016269
- Marketing start
- Listing expires
- Other FDA classes
- Increased Diuresis (Physiologic effect)Osmotic Activity (Mechanism)
- Identifiers
- Product ID 0404-9905_f3bb5de6-286d-4efc-a55d-e0b65dc4b1c2SPL ID f3bb5de6-286d-4efc-a55d-e0b65dc4b1c2SPL set ID e2444db1-9dfe-451f-a33c-9b00786464d2RxCUI 311450UNII 3OWL53L36A
- Pharmacologic class
- Osmotic Diuretic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400404990550followed by a unit qualifier and the quantityPackage 00404-9905-50. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Mannitol Injection is indicated for the reduction of: intracranial pressure and treatment of cerebral edema. elevated intraocular pressure. Mannitol Injection is an osmotic diuretic, indicated for the reduction of: intracranial pressure and treatment of cerebral edema. (1) elevated intraocular pressure. (1)
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 016269
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.