PAROXETINE

Product NDC
60429-734
11-digit product format
604290734
Labeler code
60429
Product ID
60429-734_43d3982d-7dba-7704-e063-6394a90a9988
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
paroxetine hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA075356
Marketing category
ANDA
Marketing start
2003-07-30
Substance
PAROXETINE HYDROCHLORIDE ANHYDROUS
Active strength
10 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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE ANHYDROUS10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3I3T11UD2S
Rxcui1738483, 1738495, 1738503, 1738511

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
60429-734-10PAROXETINE1000 in 1 BOTTLETABLET, FILM COATED100016
60429-734-30PAROXETINE30 in 1 BOTTLETABLET, FILM COATED3016
60429-734-90PAROXETINE90 in 1 BOTTLETABLET, FILM COATED9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60429-734-01EA - Each60429-734488c9738-c32b-4829-9bd6-47add2ceec5712013-11-04
60429-734-10EA - Each60429-7349c3cc279-bfbf-4918-abc3-9fdba3b7244312013-11-04
60429-734-30EA - Each60429-734e4a4aea4-31b5-415b-8d7c-1fcbe9023b4612012-07-24
60429-734-90EA - Each60429-7349cf0f0cf-03db-4219-afe9-acf59202494512012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60429-734PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]14Current NDC, Legacy NDC, 3 package rows20250130_e63fe922-b35a-406c-8737-f3f5e6d5a30d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSNe63fe922-b35a-406c-8737-f3f5e6d5a30d17
1738495PARoxetine HCl 20 MG Oral TabletPSNe63fe922-b35a-406c-8737-f3f5e6d5a30d17
1738503PARoxetine HCl 30 MG Oral TabletPSNe63fe922-b35a-406c-8737-f3f5e6d5a30d17
1738511PARoxetine HCl 40 MG Oral TabletPSNe63fe922-b35a-406c-8737-f3f5e6d5a30d17
1738483paroxetine hydrochloride 10 MG Oral TabletSCDe63fe922-b35a-406c-8737-f3f5e6d5a30d17
1738495paroxetine hydrochloride 20 MG Oral TabletSCDe63fe922-b35a-406c-8737-f3f5e6d5a30d17
1738503paroxetine hydrochloride 30 MG Oral TabletSCDe63fe922-b35a-406c-8737-f3f5e6d5a30d17
1738511paroxetine hydrochloride 40 MG Oral TabletSCDe63fe922-b35a-406c-8737-f3f5e6d5a30d17
1738483PARoxetine HCl 10 MG Oral TabletPSN4e2a2cd6-522c-453d-aaa7-4ad9abcaeef11
1738483paroxetine hydrochloride 10 MG Oral TabletSCD4e2a2cd6-522c-453d-aaa7-4ad9abcaeef11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60429-734-10604290734101000 TABLET, FILM COATED in 1 BOTTLE (60429-734-10) 2019-01-010000-00-00NoNoCurrent
60429-734-306042907343030 TABLET, FILM COATED in 1 BOTTLE (60429-734-30) 2019-01-010000-00-00NoNoCurrent
60429-734-906042907349090 TABLET, FILM COATED in 1 BOTTLE (60429-734-90) 2019-01-010000-00-00NoNoCurrent