FDA.reportPublic FDA data

PAROXETINE

Product NDC
71610-992
11-digit product format
716100992
Labeler code
71610
Product ID
71610-992_4d3b40a4-5332-7664-e063-6394a90aed00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA075356
Marketing category
ANDA
Marketing start
2003-07-30
Substance
PAROXETINE HYDROCHLORIDE ANHYDROUS
Active strength
40 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 HYDROCHLORIDE ANHYDROUS40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3I3T11UD2S
Rxcui1738511

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
71610-992-30PAROXETINE30 in 1 BOTTLETABLET, FILM COATED301
71610-992-45PAROXETINE45 in 1 BOTTLETABLET, FILM COATED451
71610-992-53PAROXETINE60 in 1 BOTTLETABLET, FILM COATED601
71610-992-60PAROXETINE90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-992-30EA - Each71610-9925a24e64f-4e19-4bc1-8294-a7ac2557e47112026-04-20
71610-992-45EA - Each71610-9920fe3a389-fddf-4ea9-967f-f3856b038b2912026-04-20
71610-992-53EA - Each71610-992b6a2eb77-a001-4e6c-8e13-69b150b29a3912026-04-20
71610-992-60EA - Each71610-992eb2c16ba-ff76-4a41-bc65-a0a28215a44a12026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738511PARoxetine HCl 40 MG Oral TabletPSN4d3b4536-7900-223c-e063-6294a90a3d601
1738511paroxetine hydrochloride 40 MG Oral TabletSCD4d3b4536-7900-223c-e063-6294a90a3d601

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71610-992-307161009923030 TABLET, FILM COATED in 1 BOTTLE (71610-992-30) 2026-03-17NoNoCurrent
71610-992-457161009924545 TABLET, FILM COATED in 1 BOTTLE (71610-992-45) 2026-03-17NoNoCurrent
71610-992-537161009925360 TABLET, FILM COATED in 1 BOTTLE (71610-992-53) 2026-03-17NoNoCurrent
71610-992-607161009926090 TABLET, FILM COATED in 1 BOTTLE (71610-992-60) 2026-03-17NoNoCurrent