What is NDC 71205-544?

71205-544 is the product NDC for Modafinil, Modafinil 200 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.

Proficient Rx LP, NDC labeler code 71205. 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 71205-544 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)71205-544Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71205-0544Add 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
71205-544-30	7120505443071205054430	30 TABLET in 1 BOTTLE (71205-544-30)Marketed from Mar 16, 2021
71205-544-60	7120505446071205054460	60 TABLET in 1 BOTTLE (71205-544-60)Marketed from Mar 16, 2021
71205-544-90	7120505449071205054490	90 TABLET in 1 BOTTLE (71205-544-90)Marketed from Mar 16, 2021

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: Proficient Rx LPNDC labeler code 71205
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202566
Marketing start: Sep 27, 2012
Listing expires: Dec 31, 2027
DEA schedule: CIV
Other FDA classes: Central Nervous System Stimulation (Physiologic effect)Increased Sympathetic Activity (Physiologic effect)
Identifiers: Product ID 71205-544_4ecc62bd-49b3-4202-bf5c-91b49c4c2923SPL ID 4ecc62bd-49b3-4202-bf5c-91b49c4c2923SPL set ID d97684d7-c236-451e-99bd-b8df4bf36643RxCUI 205324UNII R3UK8X3U3DUPC 0371205544300
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

N471205054430 followed by a unit qualifier and the quantity

Package 71205-0544-30. 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 Jun 1, 2023.

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 71205-544

What is NDC 71205-544?: 71205-544 is the product NDC for Modafinil, Modafinil 200 mg/1 tablet, listed with the FDA by Proficient Rx LP. 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?: Proficient Rx LP, NDC labeler code 71205. 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 202566

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

FDA NDC Directory listings under ANDA 202566
Product	Strength	Form · route	Labeler	Product NDC
Modafinil	Modafinil 100 mg/1	TabletOral	AvPAK	50268-570
Modafinil	Modafinil 200 mg/1	TabletOral	AvPAK	50268-571
Modafinil	Modafinil 100 mg/1	TabletOral	Rising Pharma Holdings, Inc.	57237-154
Modafinil	Modafinil 200 mg/1	TabletOral	Rising Pharma Holdings, Inc.	57237-155
Modafinil	Modafinil 200 mg/1	TabletOral	Bryant Ranch Prepack	63629-7315
Modafinil	Modafinil 100 mg/1	TabletOral	Aurobindo Pharma Limited	65862-601
Modafinil	Modafinil 100 mg/1	TabletOral	NuCare Pharmaceuticals,Inc.	68071-5121
Modafinil	Modafinil 100 mg/1	TabletOral	American Health Packaging	68084-621
Modafinil	Modafinil 200 mg/1	TabletOral	American Health Packaging	68084-721
Modafinil	Modafinil 100 mg/1	TabletOral	Proficient Rx LP	71205-477
Modafinil	Modafinil 100 mg/1	TabletOral	Bryant Ranch Prepack	71335-1122
Modafinil	Modafinil 200 mg/1	TabletOral	Bryant Ranch Prepack	71335-1173
Modafinil	Modafinil 100 mg/1	TabletOral	ASCLEMED USA INC.	87063-306
Modafinil	Modafinil 200 mg/1	TabletOral	ASCLEMED USA INC.	87063-307