What is NDC 71610-976?

71610-976 is the product NDC for Modafinil, Modafinil 100 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.

Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. 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 71610-976 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71610-976Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71610-0976Add 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
71610-976-30	7161009763071610097630	30 TABLET in 1 BOTTLE (71610-976-30)Marketed from Dec 17, 2025
71610-976-53	7161009765371610097653	60 TABLET in 1 BOTTLE (71610-976-53)Marketed from Dec 17, 2025
71610-976-60	7161009766071610097660	90 TABLET in 1 BOTTLE (71610-976-60)Marketed from Dec 17, 2025

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 — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 209966
Marketing start: Feb 15, 2019
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 71610-976_463bbc40-763f-4ba5-e063-6394a90a1352SPL ID 463bbc40-763f-4ba5-e063-6394a90a1352SPL set ID 463bb960-a0b5-4ca4-e063-6294a90a683bRxCUI 260218UNII 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

N471610097630 followed by a unit qualifier and the quantity

Package 71610-0976-30. 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 18, 2025.

Indications (excerpt from the label)

Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). Limitations of Use In OSA, modafinil is 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 and during treatment with modafinil for excessive sleepiness. Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71610-976

What is NDC 71610-976?: 71610-976 is the product NDC for Modafinil, Modafinil 100 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 3 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 71610. 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 ANDA 209966

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

FDA NDC Directory listings under ANDA 209966
Product	Strength	Form · route	Labeler	Product NDC
Modafinil	Modafinil 100 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-960
Modafinil	Modafinil 200 mg/1	TabletOral	Golden State Medical Supply, Inc.	51407-961
Modafinil	Modafinil 100 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1051
Modafinil	Modafinil 200 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1052
Modafinil	Modafinil 200 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-873
Modafinil	Modafinil 200 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-991
Modafinil	Modafinil 100 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-005
Modafinil	Modafinil 200 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-006
Modafinil	Modafinil 200 mg/1	TabletOral	Proficient Rx LP	82804-126
Modafinil	Modafinil 100 mg/1	TabletOral	ASCLEMED USA INC.	87063-308
Modafinil	Modafinil 200 mg/1	TabletOral	ASCLEMED USA INC.	87063-309