FDA.reportPublic FDA data

Paroxetine

Product NDC
16714-183
11-digit product format
167140183
Labeler code
16714
Product ID
16714-183_0e3542cb-82a1-4a53-b814-55cfa4075ba6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA078406
Marketing category
ANDA
Marketing start
2007-07-25
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
30 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 HEMIHYDRATE30 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
16714-183-01Paroxetine30 in 1 BOTTLETABLET, FILM COATED305
16714-183-02Paroxetine90 in 1 BOTTLETABLET, FILM COATED905
16714-183-03Paroxetine1000 in 1 BOTTLETABLET, FILM COATED10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-183-01EA - Each16714-183c4611d07-9270-4eb8-9482-3abf057d05dc12022-03-09
16714-183-02EA - Each16714-183cbfac33f-e435-4f7c-b34a-09f2e727534c12022-03-09
16714-183-03EA - Each16714-183c9004450-68b1-475c-9888-c6617e28724712022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-183PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [NORTHSTAR RX LLC]4Current NDC, Legacy NDC, 3 package rows20250410_118320de-0632-4139-8b13-7428b41da0ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSN118320de-0632-4139-8b13-7428b41da0ac5
1738495PARoxetine HCl 20 MG Oral TabletPSN118320de-0632-4139-8b13-7428b41da0ac5
1738503PARoxetine HCl 30 MG Oral TabletPSN118320de-0632-4139-8b13-7428b41da0ac5
1738511PARoxetine HCl 40 MG Oral TabletPSN118320de-0632-4139-8b13-7428b41da0ac5
1738483paroxetine hydrochloride 10 MG Oral TabletSCD118320de-0632-4139-8b13-7428b41da0ac5
1738495paroxetine hydrochloride 20 MG Oral TabletSCD118320de-0632-4139-8b13-7428b41da0ac5
1738503paroxetine hydrochloride 30 MG Oral TabletSCD118320de-0632-4139-8b13-7428b41da0ac5
1738511paroxetine hydrochloride 40 MG Oral TabletSCD118320de-0632-4139-8b13-7428b41da0ac5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-183-011671401830130 TABLET, FILM COATED in 1 BOTTLE (16714-183-01) 2007-07-250000-00-00NoNoCurrent
16714-183-021671401830290 TABLET, FILM COATED in 1 BOTTLE (16714-183-02) 2007-07-250000-00-00NoNoCurrent
16714-183-03167140183031000 TABLET, FILM COATED in 1 BOTTLE (16714-183-03) 2007-07-250000-00-00NoNoCurrent