FDA.reportPublic FDA data

Paroxetine Hydrochloride

Product NDC
62175-470
11-digit product format
621750470
Labeler code
62175
Product ID
62175-470_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
12.5 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 HYDROCHLORIDE12.5 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
62175-470-32Paroxetine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE3015
62175-470-41Paroxetine 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
62175-470-32EA - Each62175-4706a2aff0f-d0c6-4444-872e-2f69e1b6872212016-07-19
62175-470-41EA - Each62175-4709f53dd8d-6e64-4cca-9ecd-5cea552e2d6f12016-07-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62175-470PAROXETINE 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
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
62175-470-326217504703230 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-470-32) 2014-10-310000-00-00NoNoCurrent
62175-470-4162175047041500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62175-470-41) 2014-10-310000-00-00NoNoCurrent