NDC codes

FDA NDC Directory
Product NDC (as listed)70518-4398Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70518-4398Add 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
70518-4398-07051843980030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-4398-0)Marketed from Jul 24, 2025

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 — 2 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
REMEDYREPACK INC.NDC labeler code 70518
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 70518-4398_5b20f7a9-774a-bf90-e063-6294a90a480dSPL ID 5b20f7a9-774a-bf90-e063-6294a90a480dSPL set ID 9dfe774a-2c7a-4e10-bedd-cde64ad28676RxCUI 485442UNII 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

N470518439800 followed by a unit qualifier and the quantity

Package 70518-4398-00. 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 ( 1 )…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70518-4398

What is NDC 70518-4398?
70518-4398 is the product NDC for Eszopiclone, Eszopiclone 2 mg/1 tablet, film coated, listed with the FDA by REMEDYREPACK 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?
REMEDYREPACK INC., NDC labeler code 70518. 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?
89 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.70518-436170518-4361-0070518-4361-01
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 coatedOralProficient Rx LP82804-15982804-0159-3082804-0159-6082804-0159-90
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 coatedOralPreferred Pharmaceuticals Inc.68788-838768788-8387-0368788-8387-06
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-357670518-3576-0070518-3576-0170518-3576-02
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralBionpharma Inc.69452-34869452-0348-20

All 90 Eszopiclone NDCs

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 3 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-3576
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 2 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-300
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralAdvanced Rx Pharmacy of Tennessee, LLC80425-0168
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-299
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralMacleods Pharmaceuticals Limited33342-301
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralProficient Rx LP63187-970
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-7029
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralQuality Care Products LLC55700-581
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralQuality Care Products LLC55700-610
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-024
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-7169
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-026
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-027
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8826
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralDIRECT RX61919-033
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0065
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0062

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