FDA.reportPublic FDA data

Paroxetine

Product NDC
16714-181
11-digit product format
167140181
Labeler code
16714
Product ID
16714-181_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
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
16714-181-01Paroxetine30 in 1 BOTTLETABLET, FILM COATED305
16714-181-02Paroxetine90 in 1 BOTTLETABLET, FILM COATED905
16714-181-03Paroxetine100 in 1 BOTTLETABLET, FILM COATED1005
16714-181-04Paroxetine500 in 1 BOTTLETABLET, FILM COATED5005
16714-181-05Paroxetine1000 in 1 BOTTLETABLET, FILM COATED10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-181-01EA - Each16714-1814d8e385d-d40c-47e5-a1f1-65b43cc39dca12022-03-09
16714-181-02EA - Each16714-181b3781dc2-ae46-41f1-b4c5-e4da3856799812022-03-09
16714-181-03EA - Each16714-18162c3324f-835d-436b-8a8b-95d23d83624a12022-03-09
16714-181-04EA - Each16714-1815397ab0a-3d9b-407b-9076-b34b9eec416612022-03-09
16714-181-05EA - Each16714-18144a8367e-6b7e-4734-9d04-45c63d579b6312022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-181PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [NORTHSTAR RX LLC]4Current NDC, Legacy NDC, 5 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
16714-181-011671401810130 TABLET, FILM COATED in 1 BOTTLE (16714-181-01) 2007-07-250000-00-00NoNoCurrent
16714-181-021671401810290 TABLET, FILM COATED in 1 BOTTLE (16714-181-02) 2007-07-250000-00-00NoNoCurrent
16714-181-0316714018103100 TABLET, FILM COATED in 1 BOTTLE (16714-181-03) 2007-07-250000-00-00NoNoCurrent
16714-181-0416714018104500 TABLET, FILM COATED in 1 BOTTLE (16714-181-04) 2007-07-250000-00-00NoNoCurrent
16714-181-05167140181051000 TABLET, FILM COATED in 1 BOTTLE (16714-181-05) 2007-07-250000-00-00NoNoCurrent