NDC codes

FDA NDC Directory
Product NDC (as listed)31722-855Labeler and product segments. Claims need a package NDC.
Product NDC at billing width31722-0855Add 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
31722-855-0131722085501100 TABLET, FILM COATED in 1 BOTTLE (31722-855-01)Marketed from Jan 4, 2024
31722-855-303172208553030 TABLET, FILM COATED in 1 BOTTLE (31722-855-30)Marketed from Jan 4, 2024

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 — 1 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Camber Pharmaceuticals, Inc.NDC labeler code 31722
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 205504
Marketing start
Listing expires
DEA schedule
CIV
Identifiers
Product ID 31722-855_2e8f0952-b678-2e0a-e063-6294a90aaf4eSPL ID 2e8f0952-b678-2e0a-e063-6294a90aaf4eSPL set ID 00fc3250-3e29-4a4b-ac0c-74910659337cRxCUI 485440, 485442, 485465UNII UZX80K71OEUPC 0331722856300, 0331722857307, 0331722855303

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

N431722085501 followed by a unit qualifier and the quantity

Package 31722-0855-01. 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

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 31722-855

What is NDC 31722-855?
31722-855 is the product NDC for Eszopiclone, Eszopiclone 1 mg/1 tablet, film coated, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 2 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?
Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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.70518-439870518-4398-00
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 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
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralBionpharma Inc.69452-34769452-0347-1369452-0347-20

All 90 Eszopiclone NDCs

Other NDCs under ANDA 205504

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

FDA NDC Directory listings under ANDA 205504
ProductStrengthForm · routeLabelerProduct NDC
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralREMEDYREPACK INC.70518-4361
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralProficient Rx LP82804-159
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-856
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-857

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