NDC codes

FDA NDC Directory
Product NDC (as listed)0404-9905Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00404-9905Add 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
0404-9905-5000404990550004049905501 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.NDC labeler code 0404
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.

How CPT relates to drug billing

NDC on a medical claim

N400404990550 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

About NDC 0404-9905

What is NDC 0404-9905?
0404-9905 is the product NDC for Mannitol, Mannitol 12.5 g/50mL injection, solution, listed with the FDA by Henry Schein, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Mannitol.
What is the active ingredient?
Mannitol.
Who is the labeler?
Henry Schein, Inc., NDC labeler code 0404. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mannitol?
6 other product NDCs are listed under this name. See all Mannitol NDCs.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Mannitol NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
MannitolMannitol 12.5 g/50mLInjection, SolutionIntravenousHF Acquisition Co LLC, DBA HealthFirst51662-146851662-1468-0151662-1468-03
MannitolMannitol 20 g/100mLInjection, SolutionIntravenousICU Medical Inc.0990-771500990-7715-0200990-7715-03
MannitolMannitol 12.5 g/50mLInjection, SolutionIntravenousHospira, Inc.0409-403100409-4031-01
MannitolMannitol 250 mg/mLInjection, SolutionIntravenousFresenius Kabi USA, LLC63323-02463323-0024-25
MannitolMannitol 250 mg/mLInjection, SolutionIntravenousProPharma Distribution84549-02484549-0024-25
MannitolMannitol 20 g/100mLInjection, SolutionIntravenousB. Braun Medical Inc.0264-757800264-7578-1000264-7578-20

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, SolutionIntravenousHF Acquisition Co LLC, DBA HealthFirst51662-1468

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