FDA.reportPublic FDA data

Paroxetine

Product NDC
76420-716
11-digit product format
764200716
Labeler code
76420
Product ID
76420-716_2e000f86-0592-a362-e063-6394a90a169d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA077584
Marketing category
ANDA
Marketing start
2007-04-13
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
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 HYDROCHLORIDE HEMIHYDRATE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738483, 1738495, 1738503, 1738511

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
76420-716-01Paroxetine100 in 1 BOTTLETABLET, FILM COATED1002
76420-716-05Paroxetine500 in 1 BOTTLETABLET, FILM COATED5002
76420-716-10Paroxetine1000 in 1 BOTTLETABLET, FILM COATED10002
76420-716-30Paroxetine30 in 1 BOTTLETABLET, FILM COATED302
76420-716-60Paroxetine60 in 1 BOTTLETABLET, FILM COATED602
76420-716-90Paroxetine90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-716PAROXETINE TABLET, FILM COATED [ASCLEMED USA, INC.]2Current NDC, 6 package rows20250215_4acd3e7a-4f19-4428-9452-48ce370cb3db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSN4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738495PARoxetine HCl 20 MG Oral TabletPSN4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738503PARoxetine HCl 30 MG Oral TabletPSN4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738511PARoxetine HCl 40 MG Oral TabletPSN4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738483paroxetine hydrochloride 10 MG Oral TabletSCD4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738495paroxetine hydrochloride 20 MG Oral TabletSCD4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738503paroxetine hydrochloride 30 MG Oral TabletSCD4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738511paroxetine hydrochloride 40 MG Oral TabletSCD4acd3e7a-4f19-4428-9452-48ce370cb3db2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
76420-716-0176420071601100 TABLET, FILM COATED in 1 BOTTLE (76420-716-01) 2024-05-06NoNoHistorical
76420-716-0576420071605500 TABLET, FILM COATED in 1 BOTTLE (76420-716-05) 2024-05-06NoNoHistorical
76420-716-10764200716101000 TABLET, FILM COATED in 1 BOTTLE (76420-716-10) 2024-05-06NoNoHistorical
76420-716-307642007163030 TABLET, FILM COATED in 1 BOTTLE (76420-716-30) 2024-05-06NoNoHistorical
76420-716-607642007166060 TABLET, FILM COATED in 1 BOTTLE (76420-716-60) 2024-05-06NoNoHistorical
76420-716-907642007169090 TABLET, FILM COATED in 1 BOTTLE (76420-716-90) 2024-05-06NoNoHistorical