FDA.reportPublic FDA data

Sertraline hydrochloride

Product NDC
70010-204
11-digit product format
700100204
Labeler code
70010
Product ID
70010-204_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
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
Rxcui312938, 312940, 312941

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
70010-204-01Sertraline hydrochloride100 in 1 BOTTLETABLET, FILM COATED1004
70010-204-03Sertraline hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
70010-204-05Sertraline hydrochloride500 in 1 BOTTLETABLET, FILM COATED5004
70010-204-09Sertraline hydrochloride90 in 1 BOTTLETABLET, FILM COATED904
70010-204-10Sertraline hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10004
70010-204-53Sertraline hydrochloride3000 in 1 BOTTLETABLET, FILM COATED30004
70010-204-63Sertraline hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED104
70010-204-63Sertraline hydrochloride8 in 1 CARTONTABLET, FILM COATED84

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-204-03EA - Each70010-2042747bee1-90bd-474f-bab2-ff593ac6519f12023-06-06
70010-204-05EA - Each70010-20415a3c678-9083-4a4e-9dcf-0d7f57982b2212023-06-06
70010-204-09EA - Each70010-204f51d6a97-9823-49f4-913f-f34cb0de3db812023-06-06
70010-204-10EA - Each70010-204d8837a9d-8928-4b58-956f-e6b8a545b0cc12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-204SERTRALINE 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
312941sertraline HCl 50 MG Oral TabletPSN9d49e2cb-a852-403d-b92b-e7d3fa88032c5
312941sertraline 50 MG Oral TabletSCD9d49e2cb-a852-403d-b92b-e7d3fa88032c5
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY9d49e2cb-a852-403d-b92b-e7d3fa88032c5
312938sertraline HCl 100 MG Oral TabletPSN98960cc1-1d44-4d89-b415-7e250cc762cc4
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 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 TabletSY98960cc1-1d44-4d89-b415-7e250cc762cc4
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY98960cc1-1d44-4d89-b415-7e250cc762cc4
312941sertraline HCl 50 MG Oral TabletPSN1fcd3f6d-a71f-b131-e063-6394a90a4b263
312941sertraline 50 MG Oral TabletSCD1fcd3f6d-a71f-b131-e063-6394a90a4b263
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY1fcd3f6d-a71f-b131-e063-6394a90a4b263
312941sertraline HCl 50 MG Oral TabletPSN4da914d0-629e-4766-b57f-6119fa8283cf2
312941sertraline 50 MG Oral TabletSCD4da914d0-629e-4766-b57f-6119fa8283cf2
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY4da914d0-629e-4766-b57f-6119fa8283cf2
312941sertraline HCl 50 MG Oral TabletPSN4ddfd698-3d47-fc0e-e063-6394a90accec1
312941sertraline HCl 50 MG Oral TabletPSN2ce05049-030f-3e8b-e063-6394a90a48851
312941sertraline 50 MG Oral TabletSCD4ddfd698-3d47-fc0e-e063-6394a90accec1
312941sertraline 50 MG Oral TabletSCD2ce05049-030f-3e8b-e063-6394a90a48851
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY4ddfd698-3d47-fc0e-e063-6394a90accec1
312941sertraline (as sertraline HCl) 50 MG Oral TabletSY2ce05049-030f-3e8b-e063-6394a90a48851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70010-204-0170010020401100 TABLET, FILM COATED in 1 BOTTLE (70010-204-01) 2023-05-15NoNoHistorical
70010-204-037001002040330 TABLET, FILM COATED in 1 BOTTLE (70010-204-03) 2023-05-15NoNoHistorical
70010-204-0570010020405500 TABLET, FILM COATED in 1 BOTTLE (70010-204-05) 2023-05-15NoNoHistorical
70010-204-097001002040990 TABLET, FILM COATED in 1 BOTTLE (70010-204-09) 2023-05-15NoNoHistorical
70010-204-10700100204101000 TABLET, FILM COATED in 1 BOTTLE (70010-204-10) 2023-05-15NoNoHistorical
70010-204-53700100204533000 TABLET, FILM COATED in 1 BOTTLE (70010-204-53) 2023-05-15NoNoHistorical
70010-204-63700100204638 BLISTER PACK in 1 CARTON (70010-204-63) / 10 TABLET, FILM COATED in 1 BLISTER PACK8 blister pack2023-05-15NoNoHistorical