Armodafinil NDC 0378-3431

NDC codes

FDA NDC Directory

Product NDC (as listed)0378-3431Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00378-3431Add 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
0378-3431-93	00378343193	30 TABLET in 1 BOTTLE, PLASTIC (0378-3431-93)Marketed from Jun 1, 2016

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): Armodafinil
Generic name (nonproprietary): armodafinil
Active ingredients: Armodafinil — 50 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Mylan Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 200043
Marketing start: Jun 1, 2016
Listing expires: Dec 31, 2026
DEA schedule: CIV
Identifiers: Product ID 0378-3431_34fcca9f-37ba-40d9-9032-6ffeeb031a36SPL ID 34fcca9f-37ba-40d9-9032-6ffeeb031a36SPL set ID de0799f7-7644-4057-a7da-75436f978c61RxCUI 724859, 724861, 724863UNII V63XWA605IUPC 0303783433936, 0303783431932, 0303783432939

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

N400378343193 followed by a unit qualifier and the quantity

Package 00378-3431-93. 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 Sep 17, 2018.

Indications (excerpt from the label)

Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive sleep apnea (OSA), narcolepsy, or shift work disorder (SWD). Limitations of Use In OSA, armodafinil 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 armodafinil tablets for excessive sleepiness. Armodafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with obstructive s…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 200043

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

FDA NDC Directory listings under ANDA 200043
Product	Strength	Form · route	Labeler	Product NDC
Armodafinil	Armodafinil 150 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-3432
Armodafinil	Armodafinil 250 mg/1	TabletOral	Mylan Pharmaceuticals Inc.	0378-3433
Armodafinil	Armodafinil 150 mg/1	TabletOral	Bryant Ranch Prepack	71335-2991