What is NDC 71335-2501?

71335-2501 is the product NDC for Modafinil, Modafinil 200 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 package NDCs, shown above in 10- and 11-digit form.

Bryant Ranch Prepack, NDC labeler code 71335. 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 71335-2501 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71335-2501Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71335-2501Add 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
71335-2501-0	7133525010071335250100	100 TABLET in 1 BOTTLE, PLASTIC (71335-2501-0)Marketed from Sep 23, 2024
71335-2501-1	7133525010171335250101	30 TABLET in 1 BOTTLE, PLASTIC (71335-2501-1)Marketed from Sep 23, 2024
71335-2501-2	7133525010271335250102	18 TABLET in 1 BOTTLE, PLASTIC (71335-2501-2)Marketed from Sep 23, 2024
71335-2501-3	7133525010371335250103	16 TABLET in 1 BOTTLE, PLASTIC (71335-2501-3)Marketed from Sep 23, 2024
71335-2501-4	7133525010471335250104	8 TABLET in 1 BOTTLE, PLASTIC (71335-2501-4)Marketed from Sep 23, 2024
71335-2501-5	7133525010571335250105	10 TABLET in 1 BOTTLE, PLASTIC (71335-2501-5)Marketed from Sep 23, 2024
71335-2501-6	7133525010671335250106	60 TABLET in 1 BOTTLE, PLASTIC (71335-2501-6)Marketed from Sep 23, 2024
71335-2501-7	7133525010771335250107	90 TABLET in 1 BOTTLE, PLASTIC (71335-2501-7)Marketed from Sep 23, 2024
71335-2501-8	7133525010871335250108	45 TABLET in 1 BOTTLE, PLASTIC (71335-2501-8)Marketed from Sep 23, 2024
71335-2501-9	7133525010971335250109	180 TABLET in 1 BOTTLE, PLASTIC (71335-2501-9)Marketed from Sep 23, 2024

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: Bryant Ranch PrepackNDC labeler code 71335
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 207196
Marketing start: Feb 21, 2024
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 71335-2501_08b24ff6-853b-4b93-bdfc-0deb84c837b4SPL ID 08b24ff6-853b-4b93-bdfc-0deb84c837b4SPL set ID 3f733d7f-1213-4534-9433-0eb99a5abc2cRxCUI 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

N471335250100 followed by a unit qualifier and the quantity

Package 71335-2501-00. 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 Sep 23, 2024.

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 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 and during treatment with modafinil tablets for excessive sleepiness. Modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 71335-2501

What is NDC 71335-2501?: 71335-2501 is the product NDC for Modafinil, Modafinil 200 mg/1 tablet, listed with the FDA by Bryant Ranch Prepack. It has 10 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?: Bryant Ranch Prepack, NDC labeler code 71335. 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	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
Modafinil	Modafinil 200 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-873	71610-0873-3071610-0873-5371610-0873-60+1 more

All 50 Modafinil NDCs

Other NDCs under ANDA 207196

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

FDA NDC Directory listings under ANDA 207196
Product	Strength	Form · route	Labeler	Product NDC
Modafinil	Modafinil 100 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-604
Modafinil	Modafinil 200 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-605
Modafinil	Modafinil 200 mg/1	TabletOral	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-862
Modafinil	Modafinil 200 mg/1	TabletOral	Preferred Pharmaceuticals Inc.	68788-8653
Modafinil	Modafinil 200 mg/1	TabletOral	Bryant Ranch Prepack	71335-2258