NDC codes

FDA NDC Directory
Product NDC (as listed)0781-8037Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-8037Add 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
0781-8037-31007818037310078180373130 TABLET in 1 BOTTLE (0781-8037-31)Marketed from Dec 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 — 150 mg/1
Dosage form
Tablet
Route
Oral
Labeler
Sandoz IncNDC labeler code 0781
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 021875
Marketing start
Marketing end
DEA schedule
CIV
Identifiers
Product ID 0781-8037_dea0ad34-a35f-42ba-a6b6-dea58a16868fSPL ID dea0ad34-a35f-42ba-a6b6-dea58a16868fSPL set ID a3341ec8-1ad4-49e2-922b-13d1b30c8c1dRxCUI 724859, 724861, 724863, 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

N400781803731 followed by a unit qualifier and the quantity

Package 00781-8037-31. 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. 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)

About NDC 0781-8037

What is NDC 0781-8037?
0781-8037 is the product NDC for Armodafinil, Armodafinil 150 mg/1 tablet, listed with the FDA by Sandoz Inc. 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?
Sandoz Inc, NDC labeler code 0781. 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 250 mg/1TabletOraldirect rx72189-13372189-0133-30

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
ProductStrengthForm · routeLabelerProduct NDC
ArmodafinilArmodafinil 50 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-3090
ArmodafinilArmodafinil 150 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-3092
NuvigilarmodafinilArmodafinil 250 mg/1TabletOralApotex Corp.60505-4850
ArmodafinilArmodafinil 50 mg/1TabletOralSandoz Inc0781-8029
ArmodafinilArmodafinil 250 mg/1TabletOralQuality Care Products LLC55700-510
ArmodafinilArmodafinil 250 mg/1TabletOraldirect rx72189-261
ArmodafinilArmodafinil 200 mg/1TabletOralSandoz Inc0781-8045
NuvigilarmodafinilArmodafinil 50 mg/1TabletOralGolden State Medical Supply, Inc.60429-001
NuvigilarmodafinilArmodafinil 150 mg/1TabletOralGolden State Medical Supply, Inc.60429-002
NuvigilarmodafinilArmodafinil 200 mg/1TabletOralGolden State Medical Supply, Inc.60429-003
NuvigilarmodafinilArmodafinil 250 mg/1TabletOralGolden State Medical Supply, Inc.60429-004
NuvigilarmodafinilArmodafinil 200 mg/1TabletOralApotex Corp.60505-4849
ArmodafinilArmodafinil 250 mg/1TabletOralTeva Pharmaceuticals USA, Inc.0093-3094
NuvigilarmodafinilArmodafinil 50 mg/1TabletOralApotex Corp.60505-4846
NuvigilarmodafinilArmodafinil 150 mg/1TabletOralApotex Corp.60505-4847
ArmodafinilArmodafinil 200 mg/1TabletOralDirectRx72189-353
ArmodafinilArmodafinil 250 mg/1TabletOralSandoz Inc0781-8053
NuvigilarmodafinilArmodafinil 150 mg/1TabletOralCephalon, LLC63459-215

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