NDC codes

FDA NDC Directory
Product NDC (as listed)0264-7578Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00264-7578Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
0264-7578-100026475781024 CONTAINER in 1 CASE (0264-7578-10) / 500 mL in 1 CONTAINERMarketed from Jul 26, 1993
0264-7578-200026475782024 CONTAINER in 1 CASE (0264-7578-20) / 250 mL in 1 CONTAINERMarketed from Jul 26, 1993

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 — 20 g/100mL
Dosage form
Injection, Solution
Route
Intravenous
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 020006
Marketing start
Listing expires
Other FDA classes
Increased Diuresis (Physiologic effect)Osmotic Activity (Mechanism)
Identifiers
Product ID 0264-7578_33171b62-3532-4eb1-b273-714d07b0e3f8SPL ID 33171b62-3532-4eb1-b273-714d07b0e3f8SPL set ID d12cc802-b538-4065-a264-f474ff3b3043RxCUI 1791403, 1791408UNII 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.

How CPT relates to drug billing

NDC on a medical claim

N400264757810 followed by a unit qualifier and the quantity

Package 00264-7578-10. 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: Reduction of intracranial pressure and treatment of cerebral edema. Reduction of elevated intraocular pressure. Mannitol Injection is an osmotic diuretic, indicated for the reduction of: • intracranial pressure and treatment of cerebral edema. • elevated intraocular pressure.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

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