NDC codes

FDA NDC Directory
Product NDC (as listed)51662-1468Labeler and product segments. Claims need a package NDC.
Product NDC at billing width51662-1468Add 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
51662-1468-15166214680150 mL in 1 VIAL, SINGLE-DOSE (51662-1468-1)Marketed from Dec 13, 2019
51662-1468-35166214680325 POUCH in 1 CASE (51662-1468-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1468-2) / 50 mL in 1 VIAL, SINGLE-DOSEMarketed from Dec 11, 2022

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
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 51662-1468_0ffaf004-4d61-3fd4-e063-6294a90a1a63SPL ID 0ffaf004-4d61-3fd4-e063-6294a90a1a63SPL set ID 999ce711-2d5b-0d7d-e053-2995a90a2689RxCUI 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.

How CPT relates to drug billing

NDC on a medical claim

N451662146801 followed by a unit qualifier and the quantity

Package 51662-1468-01. 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 following purposes in adults and pediatric patients. Therapeutic Use Reduction of intracranial pressure and brain mass. Reduction of high intraocular pressure. Diagnostic Use Measurement of glomerular filtration rate.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 016269

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 016269
ProductStrengthForm · routeLabelerProduct NDC
MannitolMannitol 12.5 g/50mLInjection, SolutionIntravenousHospira, Inc.0409-4031
MannitolMannitol 12.5 g/50mLInjection, SolutionIntravenousHenry Schein, Inc.0404-9905

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