FDA.reportPublic FDA data

Paroxetine

Product NDC
68788-8829
11-digit product format
687888829
Labeler code
68788
Product ID
68788-8829_91c5a321-e174-4d86-9a84-e5e278d45aff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride hemihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA203854
Marketing category
ANDA
Marketing start
2025-02-13
Substance
PAROXETINE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
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
Paroxetine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738483

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ace441e-5ed1-9a56-64e5-302d887093bdProduct name720250107
ba9fc237-0e76-4ac8-d3c5-cdb4df9e9f7fProduct name420220524
200c61bf-0879-1df7-72b7-b72a8497b114Product name320171006
b430fc19-562d-420b-53a2-64d42b938631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8829-1Paroxetine100 in 1 BOTTLETABLET, FILM COATED1001
68788-8829-3Paroxetine30 in 1 BOTTLETABLET, FILM COATED301
68788-8829-6Paroxetine60 in 1 BOTTLETABLET, FILM COATED601
68788-8829-8Paroxetine120 in 1 BOTTLETABLET, FILM COATED1201
68788-8829-9Paroxetine90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8829-1EA - Each68788-88290993ef2c-a809-4b32-9f73-e12d0542bdaf12025-03-04
68788-8829-3EA - Each68788-88294a6225cd-d838-42e8-adba-4a41b50ae12f12025-03-04
68788-8829-6EA - Each68788-8829ddd247ff-82a2-4109-97eb-a2376ba72bd312025-03-04
68788-8829-8EA - Each68788-88293cb51ac7-86c3-4266-bab0-a7d97070360912025-05-14
68788-8829-9EA - Each68788-88290564912d-5c8f-46fc-bf67-8684d9dc0e9212025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8829PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20250216_91c5a321-e174-4d86-9a84-e5e278d45aff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSN91c5a321-e174-4d86-9a84-e5e278d45aff1
1738483paroxetine hydrochloride 10 MG Oral TabletSCD91c5a321-e174-4d86-9a84-e5e278d45aff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8829-168788882901100 TABLET, FILM COATED in 1 BOTTLE (68788-8829-1) 2025-02-13NoNoCurrent
68788-8829-36878888290330 TABLET, FILM COATED in 1 BOTTLE (68788-8829-3) 2025-02-13NoNoCurrent
68788-8829-66878888290660 TABLET, FILM COATED in 1 BOTTLE (68788-8829-6) 2025-02-13NoNoCurrent
68788-8829-868788882908120 TABLET, FILM COATED in 1 BOTTLE (68788-8829-8) 2025-02-13NoNoCurrent
68788-8829-96878888290990 TABLET, FILM COATED in 1 BOTTLE (68788-8829-9) 2025-02-13NoNoCurrent