NDC codes

FDA NDC Directory
Product NDC (as listed)63187-970Labeler and product segments. Claims need a package NDC.
Product NDC at billing width63187-0970Add 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
63187-970-306318709703030 TABLET, FILM COATED in 1 BOTTLE (63187-970-30)Marketed from Jan 1, 2018
63187-970-606318709706060 TABLET, FILM COATED in 1 BOTTLE (63187-970-60)Marketed from Jan 1, 2018
63187-970-906318709709090 TABLET, FILM COATED in 1 BOTTLE (63187-970-90)Marketed from Jan 1, 2018

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)
Eszopiclone
Generic name (nonproprietary)
eszopiclone
Active ingredients
Eszopiclone — 2 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Proficient Rx LPNDC labeler code 63187
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 63187-970_c07cfea0-a9fa-4ed5-928f-5aab69e12793SPL ID c07cfea0-a9fa-4ed5-928f-5aab69e12793SPL set ID 5451be60-1315-4152-ad13-412e86903c8aRxCUI 485442UNII UZX80K71OEUPC 0363187970307

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

N463187097030 followed by a unit qualifier and the quantity

Package 63187-0970-30. 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 .

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 63187-970

What is NDC 63187-970?
63187-970 is the product NDC for Eszopiclone, Eszopiclone 2 mg/1 tablet, film coated, listed with the FDA by Proficient Rx LP. It has 3 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?
Proficient Rx LP, NDC labeler code 63187. 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 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 3 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-7169
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 2 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-024
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-026
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-027
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralNuCarePharmaceuticals, Inc.68071-3376
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0598
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0062
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0065
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralProficient Rx LP63187-817
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 coatedOralREMEDYREPACK INC.70518-3576
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4398
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralQuality Care Products LLC55700-610
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralQuality Care Products LLC55700-581

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