FDA.reportPublic FDA data

Paroxetine Hydrochloride

Product NDC
63629-8527
11-digit product format
636298527
Labeler code
63629
Product ID
63629-8527_d72b03fa-f81e-4eab-95aa-00c6c48ebf37
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine Hydrochloride
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204744
Marketing category
ANDA
Marketing start
2014-10-31
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
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 HYDROCHLORIDE HEMIHYDRATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738805

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
63629-8527-1Paroxetine Hydrochloride30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE30103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8527-1EA - Each63629-8527194b9950-0dcf-40c7-8cfa-496f1e5f82e612021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8527PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240113_5e47c4fb-6070-4cb4-acaa-c6e90199b55c.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-8527-16362985270130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-8527-1) 2014-10-310000-00-00NoNoCurrent