DrugDashboards

Montelukast

Montelukast · MONTELUKAST SODIUM 10 mg/1 · Tablet, Film Coated · Oral · Sandoz Inc

NDC 00781-5560-13 · 10 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK · ANDA · View full market →

The short version

9 companies supply this market — a reasonable cushion if one runs into trouble.

The numbers behind every sentence are on this page below — and the Watch button emails you when any of them move.

Medicare Part D

No Medicare Part D plan in CMS's quarterly files lists this product. That usually means it is discontinued, a repackager's listing, or a product no plan has added to its formulary.

How Part D pricing works →

NADAC price per unit

No NADAC pricing on file for this NDC — NADAC covers drugs dispensed by retail community pharmacies.

Supply fragility

Not scored — fragility is computed for NADAC-priced NDCs.

90-day shortage risk (model v2)

0.1%chance of a new FDA shortage posting for montelukast (oral solid) in the next 90 days

sole-source market

For scale: the typical drug’s chance is about 0.1% — this one is in ordinary territory.

Backtested statistical model over the whole market, not this package alone. Model details →

Regulatory

Application
ANDA200889
TE code
AB
Approval date
Aug 3, 2012
Patents / exclusivity
None on file

Shortage history

No FDA shortage reports for this drug or its presentations.

Recalls (this NDC)

No enforcement reports list this package NDC.

Manufacturers of Montelukast (Tablet, Film Coated)

LabelerStrengthFirst seenLast seen
A-S Medication SolutionsMONTELUKAST SODIUM 10 mg/1Jul 15, 2026Sep 2, 2026
Aphena Pharma Solutions - Tennessee, LLCMONTELUKAST SODIUM 10 mg/1Jul 15, 2026Sep 2, 2026
AvPAKMONTELUKAST SODIUM 10 mg/1Jul 15, 2026Sep 2, 2026
Bryant Ranch PrepackMONTELUKAST SODIUM 10 mg/1Jul 15, 2026Sep 2, 2026
Preferred Pharmaceuticals, Inc.MONTELUKAST SODIUM 10 mg/1Jul 15, 2026Sep 2, 2026
Quallent Pharmaceuticals Health LLCMONTELUKAST SODIUM 10 mg/1Jul 15, 2026Sep 2, 2026
Remedyrepack Inc.MONTELUKAST SODIUM 10 mg/1Jul 15, 2026Sep 2, 2026
Sandoz IncMONTELUKAST SODIUM 10 mg/1Jul 15, 2026Sep 2, 2026
XLCare Pharmaceuticals Inc.MONTELUKAST SODIUM 10 mg/1Jul 15, 2026Sep 2, 2026

Roster from daily NDC Directory diffs — first/last seen dates start July 2026.

Cite this page

DrugDashboards, "Montelukast — NDC 00781-5560-13," retrieved September 3, 2026, https://drugdashboards.com/drug/00781556013.

Free to cite with attribution — see how the data is put together.