NDC codes

FDA NDC Directory
Product NDC (as listed)72189-133Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72189-0133Add 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
72189-133-30721890133307218901333030 TABLET in 1 BOTTLE (72189-133-30)Marketed from Oct 15, 2020

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 — 250 mg/1
Dosage form
Tablet
Route
Oral
Labeler
direct rxNDC labeler code 72189
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 206069
Marketing start
Listing expires
DEA schedule
CIV
Identifiers
Product ID 72189-133_2c28fdcb-8329-f51c-e063-6394a90a2fe2SPL ID 2c28fdcb-8329-f51c-e063-6394a90a2fe2SPL set ID b1ba1cdd-cf57-7a8c-e053-2a95a90a2c19RxCUI 724861UNII 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

N472189013330 followed by a unit qualifier and the quantity

Package 72189-0133-30. 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 .

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 72189-133

What is NDC 72189-133?
72189-133 is the product NDC for Armodafinil, Armodafinil 250 mg/1 tablet, listed with the FDA by direct rx. 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?
direct rx, 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
ArmodafinilArmodafinil 50 mg/1TabletOralDirect_Rx72189-46472189-0464-30
ArmodafinilArmodafinil 50 mg/1TabletOralNatco Pharma USA LLC69339-17769339-0177-0369339-0177-10
ArmodafinilArmodafinil 150 mg/1TabletOralNatco Pharma USA LLC69339-17869339-0178-0369339-0178-10
ArmodafinilArmodafinil 200 mg/1TabletOralNatco Pharma USA LLC69339-17969339-0179-0369339-0179-10
ArmodafinilArmodafinil 250 mg/1TabletOralNatco Pharma USA LLC69339-18069339-0180-0369339-0180-05
ArmodafinilArmodafinil 200 mg/1TabletOralDirectRx72189-35372189-0353-30
ArmodafinilArmodafinil 250 mg/1TabletOraldirect rx72189-26172189-0261-30
ArmodafinilArmodafinil 150 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-788068788-7880-0368788-7880-0668788-7880-09
ArmodafinilArmodafinil 200 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-782668788-7826-0368788-7826-0668788-7826-09
ArmodafinilArmodafinil 200 mg/1TabletOralAurobindo Pharma Limited65862-99865862-0998-30

All 28 Armodafinil NDCs

Other NDCs under ANDA 206069

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

FDA NDC Directory listings under ANDA 206069
ProductStrengthForm · routeLabelerProduct NDC
ArmodafinilArmodafinil 50 mg/1TabletOralAurobindo Pharma Limited65862-805
ArmodafinilArmodafinil 150 mg/1TabletOralAurobindo Pharma Limited65862-806
ArmodafinilArmodafinil 250 mg/1TabletOralAurobindo Pharma Limited65862-807
ArmodafinilArmodafinil 200 mg/1TabletOralAurobindo Pharma Limited65862-998
ArmodafinilArmodafinil 200 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-7826
ArmodafinilArmodafinil 150 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-7880
ArmodafinilArmodafinil 150 mg/1TabletOralBryant Ranch Prepack71335-1193
ArmodafinilArmodafinil 250 mg/1TabletOralBryant Ranch Prepack71335-1308
ArmodafinilArmodafinil 50 mg/1TabletOralDirect_Rx72189-464

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