FDA.reportPublic FDA data

Paroxetine

Product NDC
68788-7410
11-digit product format
687887410
Labeler code
68788
Product ID
68788-7410_a3a3e9bd-930c-40be-acbb-95701c9a0fe2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA077584
Marketing category
ANDA
Marketing start
2018-06-06
Substance
PAROXETINE HYDROCHLORIDE
Active strength
30 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 HYDROCHLORIDE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738503

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
68788-7410-1Paroxetine100 in 1 BOTTLETABLET, FILM COATED1008
68788-7410-2Paroxetine28 in 1 BOTTLETABLET, FILM COATED288
68788-7410-3Paroxetine30 in 1 BOTTLETABLET, FILM COATED308
68788-7410-6Paroxetine60 in 1 BOTTLETABLET, FILM COATED608
68788-7410-8Paroxetine120 in 1 BOTTLETABLET, FILM COATED1208
68788-7410-9Paroxetine90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7410-1EA - Each68788-7410c46b15d0-cbc7-4888-9e49-e10ba1402f0112018-09-05
68788-7410-2EA - Each68788-7410755e20f6-8ff1-45ac-bbd7-917311117de912018-09-05
68788-7410-3EA - Each68788-7410b34c2e18-6063-4df9-81a7-1416b06aa93812018-09-05
68788-7410-6EA - Each68788-741098c762fd-d97e-4056-9e58-d32ec839d70d12018-09-05
68788-7410-8EA - Each68788-741019b7da57-1c92-49a6-8439-b8681989d09312018-09-05
68788-7410-9EA - Each68788-7410f2d64c27-eaad-452a-a458-3058aeba21b912018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7410PAROXETINE TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 6 package rows20240730_ee38b589-e646-4203-bea5-cc3744fe17c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738503PARoxetine HCl 30 MG Oral TabletPSNee38b589-e646-4203-bea5-cc3744fe17c38
1738503paroxetine hydrochloride 30 MG Oral TabletSCDee38b589-e646-4203-bea5-cc3744fe17c38

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7410-168788741001100 TABLET, FILM COATED in 1 BOTTLE (68788-7410-1) 2018-06-060000-00-00NoNoCurrent
68788-7410-26878874100228 TABLET, FILM COATED in 1 BOTTLE (68788-7410-2) 2018-06-060000-00-00NoNoCurrent
68788-7410-36878874100330 TABLET, FILM COATED in 1 BOTTLE (68788-7410-3) 2018-06-060000-00-00NoNoCurrent
68788-7410-66878874100660 TABLET, FILM COATED in 1 BOTTLE (68788-7410-6) 2018-06-060000-00-00NoNoCurrent
68788-7410-868788741008120 TABLET, FILM COATED in 1 BOTTLE (68788-7410-8) 2018-06-060000-00-00NoNoCurrent
68788-7410-96878874100990 TABLET, FILM COATED in 1 BOTTLE (68788-7410-9) 2018-06-060000-00-00NoNoCurrent