Sertraline

Product NDC
57297-353
11-digit product format
572970353
Labeler code
57297
Product ID
57297-353_eb14d261-675a-418d-a62d-81453d423180
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
LUPIN LIMITED
Application
ANDA077670
Marketing category
ANDA
Marketing start
2007-02-06
Marketing end
0000-00-00
Substance
SERTRALINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57297-353-012024-12-06C16284748780-19d75b9d1-1cf2-f424-e053-dadaa90a57ce9e914b27-baba-4eb0-8b1c-ac09828a14c2
57297-353-022024-12-06C16284748780-19d75b9d1-1cf2-f424-e053-dadaa90a57ce9e914b27-baba-4eb0-8b1c-ac09828a14c2
57297-353-032024-12-06C16284748780-19d75b9d1-1cf2-f424-e053-dadaa90a57ce9e914b27-baba-4eb0-8b1c-ac09828a14c2
57297-353-052024-12-06C16284748780-19d75b9d1-1cf2-f424-e053-dadaa90a57ce9e914b27-baba-4eb0-8b1c-ac09828a14c2
57297-353-062024-12-06C16284748780-19d75b9d1-1cf2-f424-e053-dadaa90a57ce9e914b27-baba-4eb0-8b1c-ac09828a14c2
57297-353-092024-12-06C16284748780-19d75b9d1-1cf2-f424-e053-dadaa90a57ce9e914b27-baba-4eb0-8b1c-ac09828a14c2
57297-353-112024-12-06C16284748780-19d75b9d1-1cf2-f424-e053-dadaa90a57ce9e914b27-baba-4eb0-8b1c-ac09828a14c2
57297-353-012020-01-31C16284748780-19d75b9d1-1cf2-f424-e053-dadaa90a57ce9e914b27-baba-4eb0-8b1c-ac09828a14c2
57297-353-022020-01-31C16284748780-19d75b9d1-1cf2-f424-e053-dadaa90a57ce9e914b27-baba-4eb0-8b1c-ac09828a14c2
57297-353-032020-01-31C16284748780-19d75b9d1-1cf2-f424-e053-dadaa90a57ce9e914b27-baba-4eb0-8b1c-ac09828a14c2
57297-353-052020-01-31C16284748780-19d75b9d1-1cf2-f424-e053-dadaa90a57ce9e914b27-baba-4eb0-8b1c-ac09828a14c2
57297-353-062020-01-31C16284748780-19d75b9d1-1cf2-f424-e053-dadaa90a57ce9e914b27-baba-4eb0-8b1c-ac09828a14c2
57297-353-092020-01-31C16284748780-19d75b9d1-1cf2-f424-e053-dadaa90a57ce9e914b27-baba-4eb0-8b1c-ac09828a14c2
57297-353-112020-01-31C16284748780-19d75b9d1-1cf2-f424-e053-dadaa90a57ce9e914b27-baba-4eb0-8b1c-ac09828a14c2