FDA.reportPublic FDA data

SERTRALINE HYDROCHLORIDE

Product NDC
63629-8774
11-digit product format
636298774
Labeler code
63629
Product ID
63629-8774_10bafc5f-baec-4659-93f8-b0973a59304c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SERTRALINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA076934
Marketing category
ANDA
Marketing start
2006-06-30
Substance
SERTRALINE HYDROCHLORIDE
Active strength
20 mg/mL
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 HYDROCHLORIDE20 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui861064

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
63629-8774-1SERTRALINE HYDROCHLORIDE1 in 1 CARTONSOLUTION1106
63629-8774-1SERTRALINE HYDROCHLORIDE60 mL in 1 BOTTLE, DROPPERSOLUTION60106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8774-1ML - Milliliter63629-8774769a8c93-f42e-484d-9bab-1ae67dbe35b312022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8774SERTRALINE HYDROCHLORIDE SOLUTION [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 2 package rows20240820_fa260c6c-9f6a-46a3-91ce-5665739d87e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861064sertraline HCl 20 MG in 1 mL Concentrate for Oral SolutionPSNfa260c6c-9f6a-46a3-91ce-5665739d87e7106
861064sertraline 20 MG/ML Oral SolutionSCDfa260c6c-9f6a-46a3-91ce-5665739d87e7106
861064sertraline (as sertraline hydrochloride) 20 MG per 1 ML Concentrate for Oral SolutionSYfa260c6c-9f6a-46a3-91ce-5665739d87e7106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8774-1636298774011 BOTTLE, DROPPER in 1 CARTON (63629-8774-1) / 60 mL in 1 BOTTLE, DROPPER2024-04-040000-00-00NoNoCurrent