Modafinil NDC 55253-802

NDC codes

FDA NDC Directory

Product NDC (as listed)55253-802Labeler and product segments. Claims need a package NDC.

Product NDC at billing width55253-0802Add 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 NDC	11-digit (billing)	Package	Copy
55253-802-90	55253080290	90 TABLET in 1 BOTTLE (55253-802-90)Marketed from Mar 29, 2012

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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): Modafinil
Generic name (nonproprietary): modafinil
Active ingredients: Modafinil — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: CIMA LABS INC.
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 020717
Marketing start: Mar 29, 2012
Marketing end: Feb 28, 2027
DEA schedule: CIV
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
Identifiers: Product ID 55253-802_428b6de2-f791-43db-a186-d19312a348fdSPL ID 428b6de2-f791-43db-a186-d19312a348fdSPL set ID 9f3b0bd2-72a3-411f-aeec-b533373f1a97RxCUI 205324, 260218UNII R3UK8X3U3D
Pharmacologic class: Sympathomimetic-like Agent

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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N455253080290 followed by a unit qualifier and the quantity

Package 55253-0802-90. 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 Jan 31, 2023.

Indications (excerpt from the label)

Modafinil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use In OSA, modafinil is indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. If continuous positive airway pressure (CPAP) is the treatment of choice for a patient, a maximal effort to treat with CPAP for an adequate period of time should be made prior to initiating and during treatment with modafinil for excessive sleepiness. Modafinil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)