NDC 0093-7487-19 - Montelukast Sodium

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: 0093-7487
Requested NDC: 0093-7487-19
Package NDCs from labels: 0093-7487-19, 0093-7487-56
Manufacturer: Teva Pharmaceuticals USA, Inc.
Effective date: 2021-05-19
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Montelukast Sodium - Teva Pharmaceuticals USA, Inc.	Teva Pharmaceuticals USA, Inc.	2021-05-19	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0093-7487-19	EA - Each	0093-7487	ee113742-0e03-42e2-ae71-dfd372fc85a8	1	2018-01-12
0093-7487-56	EA - Each	0093-7487	360488ce-c5c5-4e72-99f3-e8eccca8c231	1	2018-01-12

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 4 of 4 · 76 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Montelukast	MONTELUKAST	XLCare Pharmaceuticals Inc.	82d65eea-c7c9-4e16-9176-46c43f00f0f6	2023-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U1O3J18SFL
Petrochemical Detox	CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANS	Deseret Biologicals, Inc.	b38b492a-cf45-4aa2-ba7e-4573d2c4ebe5	2023-01-12	Warnings	Exact identifier unii: 368GB5141J
Montelukast Sodium	MONTELUKAST SODIUM	Dr.Reddy's Laboratories Limited	3d4451a9-d73d-b9de-68ec-853bfeff6e4b	2022-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U1O3J18SFL
montelukast sodium	MONTELUKAST SODIUM	Proficient Rx LP	2ce48faf-4504-488a-8b20-3e8d4f008fb2	2022-06-01	Warnings, Adverse reactions	Exact identifier unii: U1O3J18SFL
Montelukast Sodium	MONTELUKAST SODIUM	Proficient Rx LP	97cc4e1e-e0fd-4bb5-8f9e-b8573f5230e5	2022-05-02	Warnings, Adverse reactions	Exact identifier unii: U1O3J18SFL
Montelukast	MONTELUKAST	BluePoint Laboratories	4c411d3e-47b6-481b-b846-419ed4cbb947	2022-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U1O3J18SFL
Montelukast Sodium	MONTELUKAST SODIUM	Accord Healthcare Inc.	6eea668f-a2fa-447f-b2d5-4c754d13d9fa	2022-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U1O3J18SFL
Montelukast Sodium	MONTELUKAST SODIUM	Proficient Rx LP	83c35a3d-0bbc-4598-bf76-ab0c2903bf19	2021-07-01	Warnings, Adverse reactions	Exact identifier unii: U1O3J18SFL
Montelukast	MONTELUKAST	Aphena Pharma Solutions - Tennessee, LLC	4fe3c0d4-94ff-43ca-9d24-54676fe593fe	2021-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: U1O3J18SFL
290fd46f-1364-47d5-9982-f90f1b6bbbba			ad5a77e1-cd4c-48da-8b65-f3e97433e5df	2021-05-31	Boxed warning, Warnings, Adverse reactions	Exact identifier spl set id: ad5a77e1-cd4c-48da-8b65-f3e97433e5df
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Proficient Rx LP	901385e5-7384-4c28-a36a-7dd84c36f5fd	2021-01-01	Warnings, Adverse reactions	Exact identifier unii: U1O3J18SFL
MONTELUKAST SODIUM	MONTELUKAST SODIUM	Proficient Rx LP	54014b67-3163-4c8f-b93a-229cd231ca6b	2021-01-01	Warnings, Adverse reactions	Exact identifier unii: U1O3J18SFL
Montelukast Sodium	MONTELUKAST SODIUM	Proficient Rx LP	8a724790-e1fb-4935-bb28-ce99455be5ef	2019-11-01	Warnings, Adverse reactions	Exact identifier unii: U1O3J18SFL
MONTELUKAST	MONTELUKAST	Proficient Rx LP	9705627c-283e-4743-b261-cfeb88d96e9b	2019-11-01	Warnings, Adverse reactions	Exact identifier unii: U1O3J18SFL
Montelukast Sodium	MONTELUKAST SODIUM	Proficient Rx LP	0f2dbf17-bce0-4e09-8c22-898d93be80da	2019-11-01	Warnings, Adverse reactions	Exact identifier unii: U1O3J18SFL
MONTELUKAST SODIUM	MONTELUKAST	Proficient Rx LP	cab84c43-96a3-4868-88da-3126685edf00	2019-10-01	Warnings, Adverse reactions	Exact identifier unii: U1O3J18SFL

Reported adverse events (FAERS/openFDA)#

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