NDC codes

FDA NDC Directory
Product NDC (as listed)68071-2403Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68071-2403Add 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 NDC11-digit (billing)PackageCopy
68071-2403-36807124030330 TABLET, FILM COATED in 1 BOTTLE (68071-2403-3)Marketed from May 14, 2021

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)
Eszopiclone
Generic name (nonproprietary)
eszopiclone
Active ingredients
Eszopiclone — 3 mg/1
Dosage form
Tablet, Film coated
Route
Oropharyngeal
Labeler
NuCare Pharmaceuticals,Inc.NDC labeler code 68071
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091166
Marketing start
Listing expires
DEA schedule
CIV
Identifiers
Product ID 68071-2403_4cecb424-e5f2-e954-e063-6394a90a5a40SPL ID 4cecb424-e5f2-e954-e063-6394a90a5a40SPL set ID c24ec179-f869-746f-e053-2995a90aa1ffRxCUI 485465UNII UZX80K71OEUPC 0368071240337

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N468071240303 followed by a unit qualifier and the quantity

Package 68071-2403-03. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

Eszopiclone tablets are indicated for the treatment of insomnia. In controlled outpatient and sleep laboratory studies, eszopiclone tablets administered at bedtime decreased sleep latency and improved sleep maintenance. The clinical trials performed in support of efficacy were up to 6 months in duration. The final formal assessments of sleep latency and maintenance were performed at 4 weeks in the 6-week study (adults only), at the end of both 2-week studies (elderly only) and at the end of the 6-month study (adults only). Eszopiclone tablets are indicated for the treatment of insomnia. Eszopiclone tablets have been shown to decrease sleep latency and improve sleep maintenance ( 1 ).…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68071-2403

What is NDC 68071-2403?
68071-2403 is the product NDC for Eszopiclone, Eszopiclone 3 mg/1 tablet, film coated, listed with the FDA by NuCare Pharmaceuticals,Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Eszopiclone.
What is the active ingredient?
Eszopiclone.
Who is the labeler?
NuCare Pharmaceuticals,Inc., NDC labeler code 68071. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Eszopiclone?
88 other product NDCs are listed under this name. See all Eszopiclone 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 Eszopiclone NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-439870518-4398-00
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-436170518-4361-0070518-4361-01
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-882668788-8826-0368788-8826-06
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-040780425-0407-0180425-0407-0280425-0407-03
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-85531722-0855-0131722-0855-30
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-85631722-0856-0131722-0856-30
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-85731722-0857-0131722-0857-30
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralProficient Rx LP82804-15982804-0159-3082804-0159-6082804-0159-90
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-838768788-8387-0368788-8387-06
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-357670518-3576-0070518-3576-0170518-3576-02

All 89 Eszopiclone NDCs

Other NDCs under ANDA 091166

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

FDA NDC Directory listings under ANDA 091166
ProductStrengthForm · routeLabelerProduct NDC
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralSt Mary's Medical Park Pharmacy60760-526
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc. USA68462-382
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc. USA68462-383
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc. USA68462-384
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8387
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralProficient Rx LP71205-581
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOropharyngealProficient Rx LP71205-633
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0512
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0574
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOropharyngealBryant Ranch Prepack71335-2002
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-352
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-353
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-354
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0407
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralProficient Rx LP82804-076

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in