FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
60760-091
11-digit product format
607600091
Labeler code
60760
Product ID
60760-091_f06d2003-3e24-444a-e053-2995a90a153e
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
2019-07-09
Substance
SERTRALINE HYDROCHLORIDE
Active strength
100 mg/1
Pharmacologic classes
Cytochrome P450 2D6 Inhibitors [MoA], Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sertraline Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SERTRALINE HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312938

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
60760-091-90Sertraline Hydrochloride90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-091-90EA - Each60760-0913f1eb946-6c18-433b-b9b6-1fe63166e6fb12019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-091SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [ST. MARY'S MEDICAL PARK PHARMACY]2Current NDC, Legacy NDC, 1 package rows20221223_8d444aec-cf33-b769-e053-2995a90a54be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN8d444aec-cf33-b769-e053-2995a90a54be2
312938sertraline 100 MG Oral TabletSCD8d444aec-cf33-b769-e053-2995a90a54be2
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY8d444aec-cf33-b769-e053-2995a90a54be2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-091-906076000919090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (60760-091-90) 2019-07-090000-00-00NoNoCurrent