NDC codes

FDA NDC Directory
Product NDC (as listed)47335-588Labeler and product segments. Claims need a package NDC.
Product NDC at billing width47335-0588Add 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
47335-588-0847335058808100 TABLET, FILM COATED in 1 BOTTLE (47335-588-08)Marketed from Apr 15, 2014
47335-588-18473350588181000 TABLET, FILM COATED in 1 BOTTLE (47335-588-18)Marketed from Apr 15, 2014
47335-588-834733505888330 TABLET, FILM COATED in 1 BOTTLE (47335-588-83)Marketed from Apr 15, 2014
47335-588-8847335058888100 TABLET, FILM COATED in 1 BOTTLE (47335-588-88)Marketed from Apr 15, 2014

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 — 3 mg/1
Dosage form
Tablet, Film coated
Route
Oral
Labeler
Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 091103
Marketing start
Listing expires
DEA schedule
CIV
Identifiers
Product ID 47335-588_95e952a3-5a7d-4b4c-9ac8-b5256a4371c3SPL ID 95e952a3-5a7d-4b4c-9ac8-b5256a4371c3SPL set ID 8bb1965e-7845-4c5b-b021-38e251303d68RxCUI 485440, 485442, 485465UNII UZX80K71OEUPC 0347335586831

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

N447335058808 followed by a unit qualifier and the quantity

Package 47335-0588-08. 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.

About NDC 47335-588

What is NDC 47335-588?
47335-588 is the product NDC for Eszopiclone, Eszopiclone 3 mg/1 tablet, film coated, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 4 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?
Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. 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 091103

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

FDA NDC Directory listings under ANDA 091103
ProductStrengthForm · routeLabelerProduct NDC
EszopicloneEszopiclone 1 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.47335-586
EszopicloneEszopiclone 2 mg/1Tablet, Film coatedOralSun Pharmaceutical Industries, Inc.47335-587

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