FDA.reportPublic FDA data

PAROXETINE

Product NDC
63629-9500
11-digit product format
636299500
Labeler code
63629
Product ID
63629-9500_de9709b1-67d9-43c2-bb36-eab4f007648a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209293
Marketing category
ANDA
Marketing start
2018-09-14
Marketing end
2026-07-31
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
37.5 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
PAROXETINE

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE37.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738807

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
63629-9500-1PAROXETINE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE30104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9500-1EA - Each63629-9500075642e2-bb30-46c3-90c3-27a5e7e8095f12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9500PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED, EXTENDED RELEASE [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 1 package rows20240724_5f9031a5-1a9d-49ee-bc57-13dcae7c35a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738807PARoxetine HCl 37.5 MG 24HR Extended Release Oral TabletPSN5f9031a5-1a9d-49ee-bc57-13dcae7c35a5104
173880724 HR paroxetine hydrochloride 37.5 MG Extended Release Oral TabletSCD5f9031a5-1a9d-49ee-bc57-13dcae7c35a5104
1738807paroxetine hydrochloride 37.5 MG 24 HR Extended Release Oral TabletSY5f9031a5-1a9d-49ee-bc57-13dcae7c35a5104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-9500-16362995000130 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63629-9500-1) 2018-09-142026-07-31NoNoCurrent