FDA.reportPublic FDA data

Paroxetine

Product NDC
70518-1253
11-digit product format
705181253
Labeler code
70518
Product ID
70518-1253_48c31a65-991c-7da8-e063-6294a90aac40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride hemihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA203854
Marketing category
ANDA
Marketing start
2018-06-12
Substance
PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength
40 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Paroxetine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
Rxcui1738511

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
70518-1253-0Paroxetine30 in 1 BLISTER PACKTABLET, FILM COATED3013
70518-1253-1Paroxetine30 in 1 BOXTABLET, FILM COATED3013
70518-1253-2Paroxetine1 in 1 POUCHTABLET, FILM COATED113

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1253PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 3 package rows20250509_22174520-4b78-4841-96f7-530ba12d2cf1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738511PARoxetine HCl 40 MG Oral TabletPSN22174520-4b78-4841-96f7-530ba12d2cf113
1738511paroxetine hydrochloride 40 MG Oral TabletSCD22174520-4b78-4841-96f7-530ba12d2cf113

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-1253-07051812530030 in 1 BLISTER PACKHistorical
70518-1253-17051812530130 POUCH in 1 BOX (70518-1253-1) / 1 TABLET, FILM COATED in 1 POUCH (70518-1253-2) 30 pouch2022-01-140000-00-00NoNoCurrent
70518-1253-2705181253021 in 1 POUCHHistorical