What is NDC 46708-386?

46708-386 is the product NDC for Modafinil, Modafinil 200 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 5 package NDCs, shown above in 10- and 11-digit form.

Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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?

50 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 46708-386 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)46708-386Labeler and product segments. Claims need a package NDC.

Product NDC at billing width46708-0386Add 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
46708-386-10	46708038610	100 TABLET in 1 CARTON (46708-386-10)Marketed from Jun 30, 2017
46708-386-30	46708038630	30 TABLET in 1 BOTTLE (46708-386-30)Marketed from Jun 30, 2017
46708-386-60	46708038660	60 TABLET in 1 BOTTLE (46708-386-60)Marketed from Jun 30, 2017
46708-386-90	46708038690	90 TABLET in 1 BOTTLE (46708-386-90)Marketed from Jun 30, 2017
46708-386-91	46708038691	1000 TABLET in 1 BOTTLE (46708-386-91)Marketed from Jun 30, 2017

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: Alembic Pharmaceuticals LimitedNDC labeler code 46708
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 202700
Marketing start: Jun 30, 2017
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 46708-386_975cac47-5a4b-4a5d-a8c5-2aea808f30caSPL ID 975cac47-5a4b-4a5d-a8c5-2aea808f30caSPL set ID 5b8496fe-b647-4ce6-aeef-71245712e46fRxCUI 205324, 260218UNII R3UK8X3U3DUPC 0346708385309, 0346708386306
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

N446708038610 followed by a unit qualifier and the quantity

Package 46708-0386-10. 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 3, 2022.

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 46708-386

What is NDC 46708-386?: 46708-386 is the product NDC for Modafinil, Modafinil 200 mg/1 tablet, listed with the FDA by Alembic Pharmaceuticals Limited. It has 5 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?: Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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?: 50 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 200 mg/1	TabletOral	Aphena Pharma Solutions - Tennessee, LLC	71610-989	71610-0989-3071610-0989-5371610-0989-60
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 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 51 Modafinil NDCs

Other NDCs under ANDA 202700

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

FDA NDC Directory listings under ANDA 202700
Product	Strength	Form · route	Labeler	Product NDC
Modafinil	Modafinil 100 mg/1	TabletOral	Alembic Pharmaceuticals Limited	46708-385
Modafinil	Modafinil 100 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-385
Modafinil	Modafinil 200 mg/1	TabletOral	Alembic Pharmaceuticals Inc.	62332-386