What is NDC 43353-925?

43353-925 is the product NDC for modafinil, Modafinil 200 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for modafinil?

49 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

modafinil NDC 43353-925 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43353-925Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43353-0925Add 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
43353-925-30	4335309253043353092530	30 TABLET in 1 BOTTLE, PLASTIC (43353-925-30)Marketed from Apr 17, 2014
43353-925-53	4335309255343353092553	60 TABLET in 1 BOTTLE, PLASTIC (43353-925-53)Marketed from Apr 17, 2014

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: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 43353
Product type: Prescription drug
Marketing category: NDA authorized genericApplication NDA 020717
Marketing start: Mar 29, 2012
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 43353-925_01f751d9-8907-4a54-b2e9-f57a8f150920SPL ID 01f751d9-8907-4a54-b2e9-f57a8f150920SPL set ID cad4201c-133c-4a61-9d93-3c5e51695430RxCUI 205324UNII R3UK8X3U3D
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

N443353092530 followed by a unit qualifier and the quantity

Package 43353-0925-30. 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 Dec 19, 2017.

Indications (excerpt from the label)

INDICATIONS AND USAGE Modafinil is indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea, and shift work disorder. In OSA, modafinil is indicated as an adjunct to standard treatment(s) 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 modafinil. If modafinil is used adjunctively with CPAP, the encouragement of and periodic assessment of CPAP compliance is necessary. In all cases, careful attention to the diagnosis and treatment of the underlying sle…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43353-925

What is NDC 43353-925?: 43353-925 is the product NDC for modafinil, Modafinil 200 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: modafinil.
What is the active ingredient?: Modafinil.
Who is the labeler?: Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 43353. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for modafinil?: 49 other product NDCs are listed under this name. See all modafinil 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 modafinil NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Modafinil	Modafinil 200 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8653	68788-8653-0368788-8653-0668788-8653-09
Modafinil	Modafinil 200 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-862	23155-0862-0123155-0862-0323155-0862-05+1 more
Modafinil	Modafinil 200 mg/1	TabletOral	Bryant Ranch Prepack	71335-2501	71335-2501-0071335-2501-0171335-2501-02+7 more
Modafinil	Modafinil 200 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8280	68788-8280-0368788-8280-0668788-8280-09
Modafinil	Modafinil 100 mg/1	TabletOral	Bionpharma Inc.	69452-342	69452-0342-1369452-0342-1969452-0342-20
Modafinil	Modafinil 200 mg/1	TabletOral	Bionpharma Inc.	69452-343	69452-0343-1369452-0343-1969452-0343-20
Modafinil	Modafinil 200 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-989	71610-0989-3071610-0989-5371610-0989-60
Modafinil	Modafinil 100 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-604	23155-0604-0123155-0604-0323155-0604-05+1 more
Modafinil	Modafinil 200 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-605	23155-0605-0123155-0605-0323155-0605-05+1 more
Modafinil	Modafinil 200 mg/1	TabletOral	Bryant Ranch Prepack	71335-2258	71335-2258-0071335-2258-0171335-2258-02+7 more

All 50 modafinil NDCs

Other NDCs under NDA 020717

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

FDA NDC Directory listings under NDA 020717
Product	Strength	Form · route	Labeler	Product NDC
Modafinil	Modafinil 100 mg/1	TabletOral	CIMA LABS INC.	55253-801
Modafinil	Modafinil 200 mg/1	TabletOral	CIMA LABS INC.	55253-802
Provigilmodafinil	Modafinil 100 mg/1	TabletOral	Golden State Medical Supply, Inc.	60429-009
Provigilmodafinil	Modafinil 200 mg/1	TabletOral	Golden State Medical Supply, Inc.	60429-010
Provigilmodafinil	Modafinil 100 mg/1	TabletOral	Apotex Corp	60505-4851
Provigilmodafinil	Modafinil 200 mg/1	TabletOral	Apotex Corp	60505-4852