FDA.reportPublic FDA data

Sertraline hydrochloride

Product NDC
70010-205
11-digit product format
700100205
Labeler code
70010
Product ID
70010-205_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
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
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 HYDROCHLORIDE100 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
70010-205-01Sertraline hydrochloride100 in 1 BOTTLETABLET, FILM COATED1004
70010-205-03Sertraline hydrochloride30 in 1 BOTTLETABLET, FILM COATED304
70010-205-05Sertraline hydrochloride500 in 1 BOTTLETABLET, FILM COATED5004
70010-205-09Sertraline hydrochloride90 in 1 BOTTLETABLET, FILM COATED904
70010-205-10Sertraline hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10004
70010-205-53Sertraline hydrochloride3000 in 1 BOTTLETABLET, FILM COATED30004
70010-205-63Sertraline hydrochloride8 in 1 CARTONTABLET, FILM COATED84
70010-205-63Sertraline hydrochloride10 in 1 BLISTER PACKTABLET, FILM COATED104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70010-205-03EA - Each70010-205131d2253-dc45-4920-ae82-978476615b5012023-06-06
70010-205-05EA - Each70010-20556d441d3-2e92-4e1f-94c2-fb93a5b70f8b12023-06-06
70010-205-09EA - Each70010-20556563bae-47e2-45e8-a574-008fbbddfb2712023-06-06
70010-205-10EA - Each70010-205a07f4850-6550-435b-bf25-0a33f85aa7b712023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70010-205SERTRALINE 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 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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70010-205-0170010020501100 TABLET, FILM COATED in 1 BOTTLE (70010-205-01) 2023-05-15NoNoCurrent
70010-205-037001002050330 TABLET, FILM COATED in 1 BOTTLE (70010-205-03) 2023-05-15NoNoCurrent
70010-205-0570010020505500 TABLET, FILM COATED in 1 BOTTLE (70010-205-05) 2023-05-15NoNoCurrent
70010-205-097001002050990 TABLET, FILM COATED in 1 BOTTLE (70010-205-09) 2023-05-15NoNoCurrent
70010-205-10700100205101000 TABLET, FILM COATED in 1 BOTTLE (70010-205-10) 2023-05-15NoNoCurrent
70010-205-53700100205533000 TABLET, FILM COATED in 1 BOTTLE (70010-205-53) 2023-05-15NoNoCurrent
70010-205-63700100205638 BLISTER PACK in 1 CARTON (70010-205-63) / 10 TABLET, FILM COATED in 1 BLISTER PACK8 blister pack2023-05-15NoNoCurrent