FDA.reportPublic FDA data

Paroxetine

Product NDC
68788-8777
11-digit product format
687888777
Labeler code
68788
Product ID
68788-8777_1a9c7947-4678-481e-b557-7ebf6dc04724
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride hemihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA078902
Marketing category
ANDA
Marketing start
2025-01-01
Substance
PAROXETINE HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
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
Paroxetine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738495

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
68788-8777-1Paroxetine100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1002
68788-8777-3Paroxetine30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
68788-8777-6Paroxetine60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
68788-8777-8Paroxetine120 in 1 BOTTLE, PLASTICTABLET, FILM COATED1202
68788-8777-9Paroxetine90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8777-1EA - Each68788-8777b067b236-db14-41ee-9ccc-cdbfaaf2b60612025-02-10
68788-8777-3EA - Each68788-87779e17e238-9cab-4be1-9590-0319e384f9a312025-02-10
68788-8777-6EA - Each68788-8777859e36b9-3f4a-4cf8-8c6c-40efdf42429712025-02-10
68788-8777-8EA - Each68788-877784f3f835-6e45-42e0-9100-718bcceb545d12025-02-10
68788-8777-9EA - Each68788-87771585e163-baf9-409a-b624-b49b09bd9e2312025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8777PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 5 package rows20250101_2b2e6cd0-d779-4b7b-b3aa-85b796874ac3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738495PARoxetine HCl 20 MG Oral TabletPSN2b2e6cd0-d779-4b7b-b3aa-85b796874ac32
1738495paroxetine hydrochloride 20 MG Oral TabletSCD2b2e6cd0-d779-4b7b-b3aa-85b796874ac32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8777-168788877701100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8777-1) 2025-01-01NoNoHistorical
68788-8777-36878887770330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8777-3) 2025-01-01NoNoHistorical
68788-8777-66878887770660 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8777-6) 2025-01-01NoNoHistorical
68788-8777-868788877708120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8777-8) 2025-01-01NoNoHistorical
68788-8777-96878887770990 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (68788-8777-9) 2025-01-01NoNoHistorical