Montelukast Sodium

Product NDC: 42708-042
11-digit product format: 427080042
Labeler code: 42708
Product ID: 42708-042_bca6e13a-a9bc-1bac-e053-2a95a90a9b37
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Montelukast Sodium
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: QPharma Inc
Application: ANDA078605
Marketing category: ANDA
Marketing start: 2012-08-03
Marketing end: 0000-00-00
Substance: MONTELUKAST SODIUM
Active strength: 10 mg/1
Pharmacologic classes: Leukotriene Receptor Antagonist [EPC],Leukotriene Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
42708-042-30	2021-03-12	C162847	48780-1	ba0f9c33-5e11-a910-e053-dadaa90a0b85	4fd8127c-4a22-4a6f-839a-71167909fd5b
42708-042-30	2021-01-29	C162847	48780-1	ba0f9c33-5e11-a910-e053-dadaa90a0b85	4fd8127c-4a22-4a6f-839a-71167909fd5b

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
U1O3J18SFL	MONTELUKAST SODIUM	151767-02-1	MONTELUKAST SODIUM

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42708-042-30	42708004230	30 TABLET, FILM COATED in 1 BOTTLE (42708-042-30)	2018-03-14	0000-00-00	Yes	No	Current