Montelukast — ingredient monograph

Overview

Source: NDC Directory

Ingredient name

MONTELUKAST SODIUM

Base moiety

MONTELUKAST

RxNorm CUI

200224

UNII

U1O3J18SFL

Medication products

14

Brand names

5

Dosage forms

6

FAERS reports

174,999 · not a risk measure

Products containing this ingredient

Source: NDC Directory 14 products

MONTELUKAST Montelukast · Tablet, Chewable
Rx ANDA TE AB 1 NDC
Montelukast Powder
1 NDC
Montelukast Sodium Powder
13 NDC
Montelukast Sodium Process 2 Powder
1 NDC
SINGULAIR montelukast sodium · Granule
Rx NDA TE AB Shortage 1 NDC
SINGULAIR montelukast sodium · Tablet, Film Coated
Rx NDA TE AB 1 NDC
Montelukast Tablet, Film Coated
Rx ANDA TE AB 10 NDC
Montelukast Tablet
Rx ANDA TE AB 5 NDC
Montelukast Sodium Tablet, Film Coated
Rx ANDA TE AB 4 recalls 21 NDC
Montelukast Sodium Tablet, Coated
Rx ANDA 4 NDC
Montelukast Sodium Tablet, Chewable
Rx ANDA TE AB 2 recalls 41 NDC
Montelukast Sodium Tablet
Rx ANDA TE AB 7 NDC
Montelukast Sodium Granule
Rx ANDA TE AB 5 NDC
SINGULAIR montelukast sodium · Tablet, Chewable
Rx NDA TE AB 2 NDC

Entries without a link are products listed by the FDA that carry no approval record, therapeutic equivalence rating or official labelling, so they have no detail page. Their facts are shown inline.

By dosage form

How this ingredient is presented across the catalogue.
Dosage form	Products	Examples
TABLET, Chewable	3	MONTELUKAST, Montelukast Sodium, SINGULAIR
Powder	3	Montelukast, Montelukast Sodium, Montelukast Sodium Process 2
TABLET, Film Coated	3	SINGULAIR, Montelukast, Montelukast Sodium
Granule	2	SINGULAIR, Montelukast Sodium
Tablet	2	Montelukast, Montelukast Sodium
TABLET, Coated	1	Montelukast Sodium

Sources for this page

Dataset	Agency	Used for
NDC Directory	FDA	Ingredient name, strengths, products, labelers, packages
DailyMed RxNorm mappings	NLM	RxNorm concept identifier (RxCUI)
FAERS	FDA	Adverse event report totals