What is NDC 72189-353?

72189-353 is the product NDC for Armodafinil, Armodafinil 200 mg/1 tablet, listed with the FDA by DirectRx. It has 1 package NDC, shown above in 10- and 11-digit form.

DirectRx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Armodafinil?

27 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Armodafinil NDC 72189-353 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72189-353Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72189-0353Add 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
72189-353-30	7218903533072189035330	30 TABLET in 1 BOTTLE (72189-353-30)Marketed from Apr 29, 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): Armodafinil
Generic name (nonproprietary): armodafinil
Active ingredients: Armodafinil — 200 mg/1
Dosage form: Tablet
Route: Oral
Labeler: DirectRxNDC labeler code 72189
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 021875
Marketing start: Apr 29, 2022
Listing expires: Dec 31, 2026
DEA schedule: CIV
Identifiers: Product ID 72189-353_2c4c8cee-041f-c5ef-e063-6394a90a8cfdSPL ID 2c4c8cee-041f-c5ef-e063-6394a90a8cfdSPL set ID ddd06dab-0855-5b4e-e053-2a95a90a5e67RxCUI 861960UNII V63XWA605I

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

N472189035330 followed by a unit qualifier and the quantity

Package 72189-0353-30. 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 22, 2025.

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.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72189-353

What is NDC 72189-353?: 72189-353 is the product NDC for Armodafinil, Armodafinil 200 mg/1 tablet, listed with the FDA by DirectRx. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Armodafinil.
What is the active ingredient?: Armodafinil.
Who is the labeler?: DirectRx, NDC labeler code 72189. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Armodafinil?: 27 other product NDCs are listed under this name. See all Armodafinil 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 Armodafinil NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Armodafinil	Armodafinil 50 mg/1	TabletOral	Direct_Rx	72189-464	72189-0464-30
Armodafinil	Armodafinil 50 mg/1	TabletOral	Natco Pharma USA LLC	69339-177	69339-0177-0369339-0177-10
Armodafinil	Armodafinil 150 mg/1	TabletOral	Natco Pharma USA LLC	69339-178	69339-0178-0369339-0178-10
Armodafinil	Armodafinil 200 mg/1	TabletOral	Natco Pharma USA LLC	69339-179	69339-0179-0369339-0179-10
Armodafinil	Armodafinil 250 mg/1	TabletOral	Natco Pharma USA LLC	69339-180	69339-0180-0369339-0180-05
Armodafinil	Armodafinil 250 mg/1	TabletOral	direct rx	72189-261	72189-0261-30
Armodafinil	Armodafinil 150 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7880	68788-7880-0368788-7880-0668788-7880-09
Armodafinil	Armodafinil 200 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-7826	68788-7826-0368788-7826-0668788-7826-09
Armodafinil	Armodafinil 250 mg/1	TabletOral	direct rx	72189-133	72189-0133-30
Armodafinil	Armodafinil 200 mg/1	TabletOral	Aurobindo Pharma Limited	65862-998	65862-0998-30

All 28 Armodafinil NDCs

Other NDCs under NDA 021875

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

FDA NDC Directory listings under NDA 021875
Product	Strength	Form · route	Labeler	Product NDC
Armodafinil	Armodafinil 50 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0093-3090
Armodafinil	Armodafinil 150 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0093-3092
Nuvigilarmodafinil	Armodafinil 250 mg/1	TabletOral	Apotex Corp.	60505-4850
Armodafinil	Armodafinil 50 mg/1	TabletOral	Sandoz Inc	0781-8029
Armodafinil	Armodafinil 250 mg/1	TabletOral	Quality Care Products LLC	55700-510
Armodafinil	Armodafinil 250 mg/1	TabletOral	direct rx	72189-261
Armodafinil	Armodafinil 150 mg/1	TabletOral	Sandoz Inc	0781-8037
Armodafinil	Armodafinil 200 mg/1	TabletOral	Sandoz Inc	0781-8045
Nuvigilarmodafinil	Armodafinil 50 mg/1	TabletOral	Golden State Medical Supply, Inc.	60429-001
Nuvigilarmodafinil	Armodafinil 150 mg/1	TabletOral	Golden State Medical Supply, Inc.	60429-002
Nuvigilarmodafinil	Armodafinil 200 mg/1	TabletOral	Golden State Medical Supply, Inc.	60429-003
Nuvigilarmodafinil	Armodafinil 250 mg/1	TabletOral	Golden State Medical Supply, Inc.	60429-004
Nuvigilarmodafinil	Armodafinil 200 mg/1	TabletOral	Apotex Corp.	60505-4849
Armodafinil	Armodafinil 250 mg/1	TabletOral	Teva Pharmaceuticals USA, Inc.	0093-3094
Nuvigilarmodafinil	Armodafinil 50 mg/1	TabletOral	Apotex Corp.	60505-4846
Nuvigilarmodafinil	Armodafinil 150 mg/1	TabletOral	Apotex Corp.	60505-4847
Armodafinil	Armodafinil 250 mg/1	TabletOral	Sandoz Inc	0781-8053
Nuvigilarmodafinil	Armodafinil 150 mg/1	TabletOral	Cephalon, LLC	63459-215