PAROXETINE

Product NDC
55154-7999
11-digit product format
551547999
Labeler code
55154
Product ID
55154-7999_224dfb62-6c9f-435c-b760-434430075a5c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
ANDA075356
Marketing category
ANDA
Marketing start
2003-09-08
Substance
PAROXETINE HYDROCHLORIDE ANHYDROUS
Active strength
20 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 HYDROCHLORIDE ANHYDROUS20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3I3T11UD2S
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
55154-7999-0PAROXETINE10 in 1 BLISTER PACKTABLET, FILM COATED106
55154-7999-0PAROXETINE1 in 1 BAGTABLET, FILM COATED16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7999PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH 107, LLC]4Current NDC, Legacy NDC, 2 package rows20250213_333dfd07-61f0-4b86-b4b5-b04adf64e49f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738495PARoxetine HCl 20 MG Oral TabletPSN333dfd07-61f0-4b86-b4b5-b04adf64e49f6
1738495paroxetine hydrochloride 20 MG Oral TabletSCD333dfd07-61f0-4b86-b4b5-b04adf64e49f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-7999-0551547999001 BLISTER PACK in 1 BAG (55154-7999-0) / 10 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2003-09-080000-00-00NoNoCurrent