Unfinished product

This listing is a drug for further processing, not a finished drug product dispensed or administered to patients. It is not normally billed.

NDC codes

FDA NDC Directory
Product NDC (as listed)65862-574Labeler and product segments. Claims need a package NDC.
Product NDC at billing width65862-0574Add 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
65862-574-3565862057435658620574353500 TABLET, FILM COATED in 1 BAG (65862-574-35)Marketed from 03-AUG-12

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

Generic name (nonproprietary)
montelukast sodium
Active ingredients
Montelukast sodium — 10 mg/1
Dosage form
Tablet, Film coated
Labeler
Aurobindo Pharma LimitedNDC labeler code 65862
Product type
Drug for further processing
Marketing category
Drug for further processing
Marketing start
Listing expires
Identifiers
Product ID 65862-574_b1a296df-5b02-4504-9e2f-232f68b95c10SPL ID b1a296df-5b02-4504-9e2f-232f68b95c10

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

N465862057435 followed by a unit qualifier and the quantity

Package 65862-0574-35. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 65862-574

What is NDC 65862-574?
65862-574 is the product NDC for Montelukast Sodium, Montelukast sodium 10 mg/1 tablet, film coated, listed with the FDA by Aurobindo Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Montelukast Sodium.
What is the active ingredient?
Montelukast sodium.
Who is the labeler?
Aurobindo Pharma Limited, NDC labeler code 65862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Montelukast Sodium?
70 other product NDCs are listed under this name. See all Montelukast Sodium 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 Montelukast Sodium NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Montelukast SodiumMontelukast sodium 10 mg/1TabletOralREMEDYREPACK INC.70518-475370518-4753-00
montelukast sodiumMontelukast sodium 10 mg/1Tablet, Film coatedOralPreferred Pharmaceuticals Inc.68788-861768788-8617-0368788-8617-0668788-8617-09
Montelukast SodiumMontelukast sodium 10 mg/1TabletOralPreferred Pharmaceuticals Inc.68788-861068788-8610-0368788-8610-0668788-8610-09
Montelukast SodiumMontelukast sodium 10 mg/1TabletOralRising Pharma Holdings, Inc.16571-10016571-0100-0916571-0100-10
Montelukast SodiumMontelukast sodium 10 mg/1Tablet, Film coatedOralDirect_Rx72189-41872189-0418-3072189-0418-90
Montelukast SodiumMontelukast 5 mg/1Tablet, ChewableOralDIRECT RX72189-22372189-0223-30
Montelukast SodiummontelukastMontelukast sodium 4 mg/1Tablet, ChewableOralAmneal Pharmaceuticals LLC65162-77165162-0771-03
Montelukast SodiummontelukastMontelukast sodium 5 mg/1Tablet, ChewableOralAmneal Pharmaceuticals LLC65162-77265162-0772-03
montelukast sodiumMontelukast 5 mg/1Tablet, ChewableOralPreferred Pharmaceuticals, Inc.68788-766968788-7669-0168788-7669-0268788-7669-03+3 more
Montelukast SodiumMontelukast sodium 4 mg/1GranuleOralAurobindo Pharma Limited59651-32959651-0329-30

All 71 Montelukast Sodium NDCs

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