FDA.reportPublic FDA data

PAROXETINE

Product NDC
68180-646
11-digit product format
681800646
Labeler code
68180
Product ID
68180-646_1a9bc25c-db83-42a0-851a-30212ee10cc6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PAROXETINE
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA204134
Marketing category
ANDA
Marketing start
2017-03-06
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE25 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
68180-646-01PAROXETINE100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1009
68180-646-02PAROXETINE500 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5009
68180-646-03PAROXETINE1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10009
68180-646-06PAROXETINE30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-646-06EA - Each68180-646296fb50a-e285-4d6d-bded-a26e127df3b612017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-646PAROXETINE TABLET, FILM COATED, EXTENDED RELEASE [LUPIN PHARMACEUTICALS, INC.]9Current NDC, Legacy NDC, 4 package rows20231102_d315e0da-f829-408b-be5d-2bca2e06913c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738803PARoxetine HCl 12.5 MG 24HR Extended Release Oral TabletPSNd315e0da-f829-408b-be5d-2bca2e06913c9
1738805PARoxetine HCl 25 MG 24HR Extended Release Oral TabletPSNd315e0da-f829-408b-be5d-2bca2e06913c9
1738807PARoxetine HCl 37.5 MG 24HR Extended Release Oral TabletPSNd315e0da-f829-408b-be5d-2bca2e06913c9
173880324 HR paroxetine hydrochloride 12.5 MG Extended Release Oral TabletSCDd315e0da-f829-408b-be5d-2bca2e06913c9
173880524 HR paroxetine hydrochloride 25 MG Extended Release Oral TabletSCDd315e0da-f829-408b-be5d-2bca2e06913c9
173880724 HR paroxetine hydrochloride 37.5 MG Extended Release Oral TabletSCDd315e0da-f829-408b-be5d-2bca2e06913c9
1738803paroxetine hydrochloride 12.5 MG 24 HR Extended Release Oral TabletSYd315e0da-f829-408b-be5d-2bca2e06913c9
1738805paroxetine hydrochloride 25 MG 24 HR Extended Release Oral TabletSYd315e0da-f829-408b-be5d-2bca2e06913c9
1738807paroxetine hydrochloride 37.5 MG 24 HR Extended Release Oral TabletSYd315e0da-f829-408b-be5d-2bca2e06913c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68180-646-0168180064601100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-646-01) 2017-03-060000-00-00NoNoCurrent
68180-646-0268180064602500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-646-02) 2017-03-060000-00-00NoNoCurrent
68180-646-03681800646031000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-646-03) 2017-03-060000-00-00NoNoCurrent
68180-646-066818006460630 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68180-646-06) 2017-03-060000-00-00NoNoCurrent