NDC codes

FDA NDC Directory
Product NDC (as listed)68788-7169Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68788-7169Add 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
68788-7169-16878871690110 TABLET, FILM COATED in 1 BOTTLE (68788-7169-1)Marketed from Jun 11, 2018
68788-7169-26878871690220 TABLET, FILM COATED in 1 BOTTLE (68788-7169-2)Marketed from Jun 11, 2018
68788-7169-36878871690330 TABLET, FILM COATED in 1 BOTTLE (68788-7169-3)Marketed from Jun 11, 2018
68788-7169-66878871690660 TABLET, FILM COATED in 1 BOTTLE (68788-7169-6)Marketed from Jun 11, 2018
68788-7169-96878871690990 TABLET, FILM COATED in 1 BOTTLE (68788-7169-9)Marketed from Jun 11, 2018

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
Oral
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 202929
Marketing start
Listing expires
DEA schedule
CIV
Identifiers
Product ID 68788-7169_9dec8075-bac4-4953-b317-f88ae1005a0eSPL ID 9dec8075-bac4-4953-b317-f88ae1005a0eSPL set ID 2b5b4fbb-9b86-46c6-9508-37d3d9806decRxCUI 485465UNII 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

N468788716901 followed by a unit qualifier and the quantity

Package 68788-7169-01. 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

Label details couldn’t be retrieved right now. Open the label on DailyMed.

Other NDCs under ANDA 202929

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

FDA NDC Directory listings under ANDA 202929
ProductStrengthForm · routeLabelerProduct NDC
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-7029
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8826
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralDIRECT RX61919-033
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-2698
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralNuCarePharmaceuticals, Inc.68071-3376
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-027
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-024
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-026
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0598
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralProficient Rx LP63187-817
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0065
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0062
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0089
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralProficient Rx LP63187-843
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0116
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-301
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-299
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-300
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralQuality Care Products LLC55700-610
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralQuality Care Products LLC55700-581

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