FDA.reportPublic FDA data

NDC 51079-223-01

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51079-223
Requested NDC
51079-223-01
Package NDCs from labels
51079-223-01
Manufacturer
National Council for Prescription Drug Programs
Effective date
2013-02-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-223-01EA - Each51079-2239aefb30f-0dec-4fbd-9cdd-648220b9e42a12013-02-13
51079-223-20EA - Each51079-223d4487152-ade0-4e4d-ba36-8befe2edc35d12013-02-13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 5 · 91 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Montelukast SodiumMONTELUKAST SODIUMTorrent Pharmaceuticals Limitedda038cf6-cfad-43a4-ab8e-d81d028d60872026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Montelukast Sodium
generic name: MONTELUKAST SODIUM
montelukast sodiumMONTELUKAST SODIUMPreferred Pharmaceuticals Inc.1eeb3123-9e93-4681-8096-800a7c7acf8a2026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: montelukast sodium
generic name: MONTELUKAST SODIUM
Montelukast SodiumMONTELUKAST SODIUMPreferred Pharmaceuticals Inc.64a3b181-e8d8-4caf-9f1b-e0063d0bd94a2026-07-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Montelukast Sodium
generic name: MONTELUKAST SODIUM
Montelukast SodiumMONTELUKAST SODIUMRising Pharma Holdings, Inc.49669ac0-0bb5-4576-bed5-9e85e0d76a442026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Montelukast Sodium
generic name: MONTELUKAST SODIUM
Polyethylene Glycol (3350)POLYETHYLENE GLYCOL (3350)Mylan Institutional Inc.219bcbc4-b84a-4209-9f34-ef2b0ef0d2732026-04-08WarningsName fallback
manufacturer name: Mylan Institutional Inc.
montelukast sodiumMONTELUKAST SODIUMA-S Medication Solutions7ff11e37-9ea5-40b6-96f7-4caf27cab7562026-03-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: montelukast sodium
generic name: MONTELUKAST SODIUM
montelukast sodiumMONTELUKAST SODIUMA-S Medication Solutions1a312a28-8472-4cab-a7dd-d01cd8b2765a2026-03-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: montelukast sodium
generic name: MONTELUKAST SODIUM
montelukast sodiumMONTELUKAST SODIUMA-S Medication Solutions25b2049d-3a93-4ac3-8de6-14f5d7ce03152026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: montelukast sodium
generic name: MONTELUKAST SODIUM
montelukast sodiumMONTELUKAST SODIUMA-S Medication Solutions04b3faff-1ea1-4d2a-aa31-9d6e742e17592026-03-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: montelukast sodium
generic name: MONTELUKAST SODIUM
ChlorthalidoneCHLORTHALIDONEMylan Institutional Inc.193c85ba-43c2-4be2-82cf-7b394a83390e2026-01-20Warnings, Adverse reactionsName fallback
manufacturer name: Mylan Institutional Inc.
montelukast sodiumMONTELUKAST SODIUMPreferred Pharmaceuticals, Inc.09b0bc9e-3035-45b4-b61b-4aca708483602026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: montelukast sodium
generic name: MONTELUKAST SODIUM
Montelukast SodiumMONTELUKAST SODIUMRedpharm Drug2fbdf1be-a37f-879b-e063-6394a90aa20d2025-12-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Montelukast Sodium
generic name: MONTELUKAST SODIUM
MONTELUKAST SODIUMMONTELUKAST SODIUMChartwell RX, LLC5cb4298c-10b1-4d6f-95ad-4aad72daf2492025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: MONTELUKAST SODIUM
generic name: MONTELUKAST SODIUM
Montelukast SodiumMONTELUKAST SODIUMAvKAREed2caffa-a75c-1c27-ae30-2d8280eaea7d2025-12-16Warnings, Adverse reactionsName fallback
brand name: Montelukast Sodium
generic name: MONTELUKAST SODIUM
MONTELUKASTMONTELUKAST SODIUMA-S Medication Solutionsda9821f1-536a-416b-9594-210bde0cefaf2025-12-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: MONTELUKAST SODIUM
LevetiracetamLEVETIRACETAMMylan Institutional Inc.08e1bfea-7f3f-42d9-823d-f75080e664ff2025-11-12Warnings, Adverse reactionsName fallback
manufacturer name: Mylan Institutional Inc.
Chlordiazepoxide HydrochlorideCHLORDIAZEPOXIDE HYDROCHLORIDEMylan Institutional Inc.68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a2025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: Mylan Institutional Inc.
ClozapineCLOZAPINEMylan Institutional Inc.d5c8a456-6f3c-4963-b321-4ed746f690e42025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: Mylan Institutional Inc.
Thioridazine HydrochlorideTHIORIDAZINE HYDROCHLORIDEMylan Institutional Inc.52fea941-0b47-41c1-b00d-f88150e8ab932025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: Mylan Institutional Inc.
Divalproex SodiumDIVALPROEX SODIUMMylan Institutional Inc.b367d81d-4eca-4e28-b490-34be4c0035612025-11-11Boxed warning, Warnings, Adverse reactionsName fallback
manufacturer name: Mylan Institutional Inc.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.