Modafinil NDC 69452-343

NDC codes

FDA NDC Directory

Product NDC (as listed)69452-343Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69452-0343Add 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
69452-343-13	69452034313	30 TABLET in 1 BOTTLE, PLASTIC (69452-343-13)Marketed from Feb 28, 2022
69452-343-19	69452034319	90 TABLET in 1 BOTTLE, PLASTIC (69452-343-19)Marketed from Feb 28, 2022
69452-343-20	69452034320	100 TABLET in 1 BOTTLE, PLASTIC (69452-343-20)Marketed from Feb 28, 2022

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: Bionpharma Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 078963
Marketing start: Feb 28, 2022
Listing expires: Dec 31, 2026
DEA schedule: CIV
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
Identifiers: Product ID 69452-343_45322b3a-fdbe-466f-a2d3-b64e12b36efeSPL ID 45322b3a-fdbe-466f-a2d3-b64e12b36efeSPL set ID 63604fef-0b80-40ce-8dbf-3384f1aee395RxCUI 205324, 260218UNII R3UK8X3U3DUPC 0369452343135, 0369452342138
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

N469452034313 followed by a unit qualifier and the quantity

Package 69452-0343-13. 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 Jul 21, 2023.

Indications (excerpt from the label)

Modafinil tablets are 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 tablets are 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 tablets for excessive sleepiness. Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 078963

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

FDA NDC Directory listings under ANDA 078963
Product	Strength	Form · route	Labeler	Product NDC
Modafinil	Modafinil 200 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-989
Modafinil	Modafinil 100 mg/1	TabletOral	Bionpharma Inc.	69452-342
Modafinil	Modafinil 200 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8280