Sertraline Hydrochloride

Product NDC
60760-612
11-digit product format
607600612
Labeler code
60760
Product ID
60760-612_51182ada-a319-d6e5-e063-6294a90a242d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
�St. Mary's Medical Park Pharmacy
Application
ANDA077206
Marketing category
ANDA
Marketing start
2018-12-26
Substance
SERTRALINE HYDROCHLORIDE
Active strength
50 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sertraline Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SERTRALINE HYDROCHLORIDE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312941

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4ac594ea-ad8b-47fd-9b52-bbd98301675eProduct name120220317
255fa467-900b-5557-4215-6823352d1150Product name220211028

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60760-612-90Sertraline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-612SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, Legacy NDC, 1 package rows20190119_7f81de84-0ad7-f050-e053-2a91aa0aa762.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312941sertraline HCl 50 MG Oral TabletPSN7f81de84-0ad7-f050-e053-2a91aa0aa7622
312941sertraline 50 MG Oral TabletSCD7f81de84-0ad7-f050-e053-2a91aa0aa7622
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY7f81de84-0ad7-f050-e053-2a91aa0aa7622

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-612-906076006129090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-612-90) 2018-12-260000-00-00NoNoCurrent