NDC codes

FDA NDC Directory
Product NDC (as listed)71335-2002Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71335-2002Add 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
71335-2002-17133520020130 TABLET, FILM COATED in 1 BOTTLE (71335-2002-1)Marketed from Feb 10, 2022
71335-2002-27133520020260 TABLET, FILM COATED in 1 BOTTLE (71335-2002-2)Marketed from Feb 10, 2022
71335-2002-37133520020390 TABLET, FILM COATED in 1 BOTTLE (71335-2002-3)Marketed from Feb 10, 2022
71335-2002-471335200204120 TABLET, FILM COATED in 1 BOTTLE (71335-2002-4)Marketed from Feb 10, 2022
71335-2002-57133520020520 TABLET, FILM COATED in 1 BOTTLE (71335-2002-5)Marketed from Feb 10, 2022
71335-2002-67133520020628 TABLET, FILM COATED in 1 BOTTLE (71335-2002-6)Marketed from Feb 10, 2022
71335-2002-77133520020715 TABLET, FILM COATED in 1 BOTTLE (71335-2002-7)Marketed from Feb 10, 2022
71335-2002-871335200208100 TABLET, FILM COATED in 1 BOTTLE (71335-2002-8)Marketed from Feb 10, 2022

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
Oropharyngeal
Labeler
Bryant Ranch PrepackNDC labeler code 71335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091166
Marketing start
Listing expires
DEA schedule
CIV
Identifiers
Product ID 71335-2002_971e13a2-156d-4423-9418-0f0acb05105aSPL ID 971e13a2-156d-4423-9418-0f0acb05105aSPL set ID e04d4f8b-c9a1-4dc9-aac4-2e6376cd9a0cRxCUI 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N471335200201 followed by a unit qualifier and the quantity

Package 71335-2002-01. 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 have 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 71335-2002

What is NDC 71335-2002?
71335-2002 is the product NDC for Eszopiclone, Eszopiclone 3 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. 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?
Bryant Ranch Prepack, NDC labeler code 71335. 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 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

All 90 Eszopiclone NDCs

Other NDCs under ANDA 091166

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

FDA NDC Directory listings under ANDA 091166
ProductStrengthForm · routeLabelerProduct NDC
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralSt Mary's Medical Park Pharmacy60760-526
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralProficient Rx LP71205-581
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOropharyngealProficient Rx LP71205-633
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-354
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-352
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralAsclemed USA, Inc.76420-353
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0512
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralBryant Ranch Prepack71335-0574
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOropharyngealNuCare Pharmaceuticals,Inc.68071-2403
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralProficient Rx LP82804-076
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-8387
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralAdvanced Rx of Tennessee, LLC80425-0407
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc. USA68462-382
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc. USA68462-383
EszopicloneEszopiclone 3 mg/1Tablet, Film coatedOralGlenmark Pharmaceuticals Inc. USA68462-384

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