FDA.reportPublic FDA data

Paroxetine Hydrochloride

Product NDC
62175-471
11-digit product format
621750471
Labeler code
62175
Product ID
62175-471_9474f942-d6d8-486b-8ea6-f8c561bb5014
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA204744
Marketing category
ANDA
Marketing start
2014-10-31
Substance
PAROXETINE HYDROCHLORIDE
Active strength
25 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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738803, 1738805, 1738807

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
62175-471-32Paroxetine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3015
62175-471-41Paroxetine Hydrochloride500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE50015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62175-471-32EA - Each62175-471b98f0272-f42f-4c0b-86b4-dacd3a50762812016-07-19
62175-471-41EA - Each62175-471d74fbc99-17ba-46d9-9080-7d5cf766c61112016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62175-471PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [LANNETT COMPANY, INC.]15Current NDC, Legacy NDC, 2 package rows20230922_f22886f5-230c-47e4-9dd8-ffb14c8d6ae4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738805PARoxetine HCl 25 MG 24HR Extended Release Oral TabletPSN5e47c4fb-6070-4cb4-acaa-c6e90199b55c103
173880524 HR paroxetine hydrochloride 25 MG Extended Release Oral TabletSCD5e47c4fb-6070-4cb4-acaa-c6e90199b55c103
1738805paroxetine hydrochloride 25 MG 24 HR Extended Release Oral TabletSY5e47c4fb-6070-4cb4-acaa-c6e90199b55c103
1738803PARoxetine HCl 12.5 MG 24HR Extended Release Oral TabletPSNf22886f5-230c-47e4-9dd8-ffb14c8d6ae415
1738805PARoxetine HCl 25 MG 24HR Extended Release Oral TabletPSNf22886f5-230c-47e4-9dd8-ffb14c8d6ae415
1738807PARoxetine HCl 37.5 MG 24HR Extended Release Oral TabletPSNf22886f5-230c-47e4-9dd8-ffb14c8d6ae415
173880324 HR paroxetine hydrochloride 12.5 MG Extended Release Oral TabletSCDf22886f5-230c-47e4-9dd8-ffb14c8d6ae415
173880524 HR paroxetine hydrochloride 25 MG Extended Release Oral TabletSCDf22886f5-230c-47e4-9dd8-ffb14c8d6ae415
173880724 HR paroxetine hydrochloride 37.5 MG Extended Release Oral TabletSCDf22886f5-230c-47e4-9dd8-ffb14c8d6ae415
1738803paroxetine hydrochloride 12.5 MG 24 HR Extended Release Oral TabletSYf22886f5-230c-47e4-9dd8-ffb14c8d6ae415
1738805paroxetine hydrochloride 25 MG 24 HR Extended Release Oral TabletSYf22886f5-230c-47e4-9dd8-ffb14c8d6ae415
1738807paroxetine hydrochloride 37.5 MG 24 HR Extended Release Oral TabletSYf22886f5-230c-47e4-9dd8-ffb14c8d6ae415

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62175-471-326217504713230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-471-32) 2014-10-310000-00-00NoNoCurrent
62175-471-4162175047141500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-471-41) 2014-10-310000-00-00NoNoCurrent