montelukast sodium

Product NDC
70518-2881
11-digit product format
705182881
Labeler code
70518
Product ID
70518-2881_d7851e57-f780-142d-e053-2995a90a0315
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
montelukast sodium
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204093
Marketing category
ANDA
Marketing start
2020-09-14
Marketing end
0000-00-00
Substance
MONTELUKAST
Active strength
4 mg/1
Pharmacologic classes
Leukotriene Receptor Antagonist [EPC], Leukotriene Receptor Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2881-02022-02-08C16284748780-1d6a99b39-7bae-a426-e053-dadaa90af4c20995c29a-b614-4ceb-acd0-5236ed93b863
70518-2881-02022-01-28C16284748780-1d6a99b39-7bae-a426-e053-dadaa90af4c20995c29a-b614-4ceb-acd0-5236ed93b863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-2881-07051828810090 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (70518-2881-0) 2020-09-140000-00-00NoNoCurrent