NDC codes

FDA NDC Directory
Product NDC (as listed)0409-4031Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00409-4031Add 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
0409-4031-01004094031010040940310125 VIAL, SINGLE-DOSE in 1 TRAY (0409-4031-01) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-4031-16)Marketed from Nov 30, 2004

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
Hospira, Inc.NDC labeler code 0409
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 0409-4031_4092b5ac-45f3-4404-a790-c190eb8a3545SPL ID 4092b5ac-45f3-4404-a790-c190eb8a3545SPL set ID 8ad3145e-00e7-4412-b9a5-06f00f264f30RxCUI 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

N400409403101 followed by a unit qualifier and the quantity

Package 00409-4031-01. 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 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 0409-4031

What is NDC 0409-4031?
0409-4031 is the product NDC for Mannitol, Mannitol 12.5 g/50mL injection, solution, listed with the FDA by Hospira, 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?
Hospira, Inc., NDC labeler code 0409. 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, SolutionIntravenousHenry Schein, Inc.0404-990500404-9905-50
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 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, SolutionIntravenousHenry Schein, Inc.0404-9905
MannitolMannitol 12.5 g/50mLInjection, SolutionIntravenousHF Acquisition Co LLC, DBA HealthFirst51662-1468

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