FDA.reportPublic FDA data

Sertraline hydrochloride

Product NDC
70010-203
11-digit product format
700100203
Labeler code
70010
Product ID
70010-203_4ec654e4-0bd5-934d-e063-6294a90a218d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sertraline hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Granules Pharmaceuticals Inc.
Application
ANDA078403
Marketing category
ANDA
Marketing start
2023-05-15
Substance
SERTRALINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUTI8907Y6X
Rxcui312938, 312940, 312941

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
4ac594ea-ad8b-47fd-9b52-bbd98301675eProduct name120220317
255fa467-900b-5557-4215-6823352d1150Product name220211028

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70010-203-03Sertraline hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
70010-203-05Sertraline hydrochloride500 in 1 BOTTLETABLET, FILM COATED5004
70010-203-09Sertraline hydrochloride90 in 1 BOTTLETABLET, FILM COATED904
70010-203-10Sertraline hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10004
70010-203-50Sertraline hydrochloride50 in 1 BOTTLETABLET, FILM COATED504
70010-203-53Sertraline hydrochloride3000 in 1 BOTTLETABLET, FILM COATED30004
70010-203-63Sertraline hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED104
70010-203-63Sertraline hydrochloride8 in 1 CARTONTABLET, FILM COATED84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-203SERTRALINE HYDROCHLORIDE TABLET, FILM COATED [GRANULES PHARMACEUTICALS INC.]2Current NDC, 8 package rows20241109_98960cc1-1d44-4d89-b415-7e250cc762cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312938sertraline HCl 100 MG Oral TabletPSN98960cc1-1d44-4d89-b415-7e250cc762cc4
312940sertraline HCl 25 MG Oral TabletPSN455c8416-c878-4283-a42f-4df896870a4e4
312940sertraline HCl 25 MG Oral TabletPSN98960cc1-1d44-4d89-b415-7e250cc762cc4
312941sertraline HCl 50 MG Oral TabletPSN98960cc1-1d44-4d89-b415-7e250cc762cc4
312938sertraline 100 MG Oral TabletSCD98960cc1-1d44-4d89-b415-7e250cc762cc4
312940sertraline 25 MG Oral TabletSCD455c8416-c878-4283-a42f-4df896870a4e4
312940sertraline 25 MG Oral TabletSCD98960cc1-1d44-4d89-b415-7e250cc762cc4
312941sertraline 50 MG Oral TabletSCD98960cc1-1d44-4d89-b415-7e250cc762cc4
312938sertraline (as sertraline HCl) 100 MG Oral TabletSY98960cc1-1d44-4d89-b415-7e250cc762cc4
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY455c8416-c878-4283-a42f-4df896870a4e4
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY98960cc1-1d44-4d89-b415-7e250cc762cc4
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY98960cc1-1d44-4d89-b415-7e250cc762cc4
312940sertraline HCl 25 MG Oral TabletPSN1afd0016-d0ee-4e25-a1a4-b66f228e2f9c2
312940sertraline 25 MG Oral TabletSCD1afd0016-d0ee-4e25-a1a4-b66f228e2f9c2
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY1afd0016-d0ee-4e25-a1a4-b66f228e2f9c2
312940sertraline HCl 25 MG Oral TabletPSN4f6f2412-8085-45bf-be4f-63e44490a34e1
312940sertraline HCl 25 MG Oral TabletPSN9c0a7f78-9cac-4e82-b971-f3f9758f8a0c1
312940sertraline HCl 25 MG Oral TabletPSNf705f743-40e9-42bf-88f5-6dd7e5d5ba941
312940sertraline 25 MG Oral TabletSCD4f6f2412-8085-45bf-be4f-63e44490a34e1
312940sertraline 25 MG Oral TabletSCD9c0a7f78-9cac-4e82-b971-f3f9758f8a0c1
312940sertraline 25 MG Oral TabletSCDf705f743-40e9-42bf-88f5-6dd7e5d5ba941
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY4f6f2412-8085-45bf-be4f-63e44490a34e1
312940sertraline (as sertraline HCl) 25 MG Oral TabletSY9c0a7f78-9cac-4e82-b971-f3f9758f8a0c1
312940sertraline (as sertraline HCl) 25 MG Oral TabletSYf705f743-40e9-42bf-88f5-6dd7e5d5ba941

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70010-203-037001002030330 TABLET, FILM COATED in 1 BOTTLE (70010-203-03) 2023-05-15NoNoCurrent
70010-203-0570010020305500 TABLET, FILM COATED in 1 BOTTLE (70010-203-05) 2023-05-15NoNoCurrent
70010-203-097001002030990 TABLET, FILM COATED in 1 BOTTLE (70010-203-09) 2023-05-15NoNoCurrent
70010-203-10700100203101000 TABLET, FILM COATED in 1 BOTTLE (70010-203-10) 2023-05-15NoNoCurrent
70010-203-507001002035050 TABLET, FILM COATED in 1 BOTTLE (70010-203-50) 2023-05-15NoNoCurrent
70010-203-53700100203533000 TABLET, FILM COATED in 1 BOTTLE (70010-203-53) 2023-05-15NoNoCurrent
70010-203-63700100203638 BLISTER PACK in 1 CARTON (70010-203-63) / 10 TABLET, FILM COATED in 1 BLISTER PACK8 blister pack2023-05-15NoNoCurrent