FDA.reportPublic FDA data

Sertraline Hydrochloride

Product NDC
55700-362
11-digit product format
557000362
Labeler code
55700
Product ID
55700-362_981e0995-fc38-4963-bd59-5f314988fc5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products LLC
Application
ANDA077206
Marketing category
ANDA
Marketing start
2007-02-06
Marketing end
2027-01-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sertraline Hydrochloride

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
55700-362-00Sertraline Hydrochloride100 in 1 BOTTLETABLET, FILM COATED1009
55700-362-30Sertraline Hydrochloride30 in 1 BOTTLETABLET, FILM COATED309
55700-362-60Sertraline Hydrochloride60 in 1 BOTTLETABLET, FILM COATED609
55700-362-90Sertraline Hydrochloride90 in 1 BOTTLETABLET, FILM COATED909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-362-00EA - Each55700-362f7023c07-45e7-4195-b62b-04ed0be1685612017-12-14
55700-362-30EA - Each55700-362545d5c51-45ad-4c6f-b112-8ba001f19dab12016-12-07
55700-362-60EA - Each55700-362f33c4aa3-f761-4c7d-a00b-07bdb4e804ee12016-12-07
55700-362-90EA - Each55700-3623f8f03d8-fa70-4a76-9119-f6ef14262a7f12017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-362SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [QUALITY CARE PRODUCTS LLC]9Current NDC, Legacy NDC, 4 package rows20241219_25aef6c1-9964-44a1-a905-c37e5c28a3c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN25aef6c1-9964-44a1-a905-c37e5c28a3c09
312938sertraline 100 MG Oral TabletSCD25aef6c1-9964-44a1-a905-c37e5c28a3c09
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY25aef6c1-9964-44a1-a905-c37e5c28a3c09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-362-0055700036200100 TABLET, FILM COATED in 1 BOTTLE (55700-362-00) 2017-08-250000-00-00NoNoCurrent
55700-362-305570003623030 TABLET, FILM COATED in 1 BOTTLE (55700-362-30) 2016-01-220000-00-00NoNoCurrent
55700-362-605570003626060 TABLET, FILM COATED in 1 BOTTLE (55700-362-60) 2016-01-220000-00-00NoNoCurrent
55700-362-905570003629090 TABLET, FILM COATED in 1 BOTTLE (55700-362-90) 2017-08-252027-01-31NoNoCurrent