FDA.reportPublic FDA data

Paroxetine

Product NDC
50090-0850
11-digit product format
500900850
Labeler code
50090
Product ID
50090-0850_f2d21b86-8d34-4070-b619-987c7542885f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077584
Marketing category
ANDA
Marketing start
2007-04-13
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
50090-0850-0Paroxetine30 in 1 BOTTLETABLET, FILM COATED307
50090-0850-1Paroxetine60 in 1 BOTTLETABLET, FILM COATED607
50090-0850-2Paroxetine90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0850-0EA - Each50090-08501a15bd2b-c643-4c0a-9080-f7392127542012023-10-16
50090-0850-1EA - Each50090-085092f130a3-a48b-42aa-bbd1-af17a6b9a73c12023-10-16
50090-0850-2EA - Each50090-085034ced35d-d917-43a0-8ee6-bdb3bc33c25012023-10-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0850PAROXETINE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Current NDC, 3 package rows20230911_a809a6b5-18a3-4771-aaf8-7197d1743540.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738495PARoxetine HCl 20 MG Oral TabletPSNa809a6b5-18a3-4771-aaf8-7197d17435407
1738495paroxetine hydrochloride 20 MG Oral TabletSCDa809a6b5-18a3-4771-aaf8-7197d17435407

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-0850-05009008500030 TABLET, FILM COATED in 1 BOTTLE (50090-0850-0) 2014-11-28NoNoHistorical
50090-0850-15009008500160 TABLET, FILM COATED in 1 BOTTLE (50090-0850-1) 2014-11-28NoNoHistorical
50090-0850-25009008500290 TABLET, FILM COATED in 1 BOTTLE (50090-0850-2) 2014-11-28NoNoHistorical