NDC codes

FDA NDC Directory
Product NDC (as listed)68788-7667Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-7667Add 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
68788-7667-068788766700100 TABLET, FILM COATED in 1 BOTTLE (68788-7667-0)Marketed from Feb 28, 2020
68788-7667-16878876670110 TABLET, FILM COATED in 1 BOTTLE (68788-7667-1)Marketed from Feb 28, 2020
68788-7667-26878876670220 TABLET, FILM COATED in 1 BOTTLE (68788-7667-2)Marketed from Feb 28, 2020
68788-7667-36878876670330 TABLET, FILM COATED in 1 BOTTLE (68788-7667-3)Marketed from Feb 28, 2020
68788-7667-56878876670515 TABLET, FILM COATED in 1 BOTTLE (68788-7667-5)Marketed from Feb 28, 2020
68788-7667-66878876670660 TABLET, FILM COATED in 1 BOTTLE (68788-7667-6)Marketed from Feb 28, 2020
68788-7667-7687887667077 TABLET, FILM COATED in 1 BOTTLE (68788-7667-7)Marketed from Feb 28, 2020
68788-7667-96878876670990 TABLET, FILM COATED in 1 BOTTLE (68788-7667-9)Marketed from Feb 28, 2020

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 — 1 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Preferred Pharmaceuticals, Inc.NDC labeler code 68788
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208451
Marketing start
Listing expires
DEA schedule
CIV
Identifiers
Product ID 68788-7667_1fb749c5-2de2-4875-8a41-2eaf6747db82SPL ID 1fb749c5-2de2-4875-8a41-2eaf6747db82SPL set ID 45558f0a-83f1-49b9-ab18-f436c0be9677RxCUI 485440UNII UZX80K71OE

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

N468788766700 followed by a unit qualifier and the quantity

Package 68788-7667-00. 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 . 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 has been shown to decrease sleep latency and improve sleep maintenance…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 68788-7667

What is NDC 68788-7667?
68788-7667 is the product NDC for Eszopiclone, Eszopiclone 1 mg/1 tablet, film coated, listed with the FDA by Preferred Pharmaceuticals, Inc.. It has 8 package NDCs, 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?
Preferred Pharmaceuticals, Inc., NDC labeler code 68788. 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 208451

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

FDA NDC Directory listings under ANDA 208451
ProductStrengthForm · routeLabelerProduct NDC
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-3514
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7744
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7745
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralA-S Medication Solutions50090-7746
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-967
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralAurobindo Pharma Limited65862-969
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-1310
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralProficient Rx LP71205-236
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralProficient Rx LP71205-384
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralProficient Rx LP71205-513
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-9659
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralPD-Rx Pharmaceuticals, Inc.72789-067
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0063
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0066

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