FDA.reportPublic FDA data

Paroxetine

Product NDC
65862-157
11-digit product format
658620157
Labeler code
65862
Product ID
65862-157_19f7a08f-58bd-45b8-a750-4432ae161455
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA078406
Marketing category
ANDA
Marketing start
2007-07-25
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
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 HEMIHYDRATE40 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX2ELS050D8
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
65862-157-01Paroxetine100 in 1 BOTTLETABLET, FILM COATED10024
65862-157-05Paroxetine500 in 1 BOTTLETABLET, FILM COATED50024
65862-157-30Paroxetine30 in 1 BOTTLETABLET, FILM COATED3024
65862-157-90Paroxetine90 in 1 BOTTLETABLET, FILM COATED9024
65862-157-99Paroxetine1000 in 1 BOTTLETABLET, FILM COATED100024

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-157-30EA - Each65862-1579d2f0d3d-83d4-43f8-8777-ead91b2bddbe12012-07-24
65862-157-99EA - Each65862-157a27aeb55-04f7-4057-9d53-66ff50ed537512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAROXETINE HYDROCHLORIDE HEMIHYDRATEACTIVE INGREDIENTX2ELS050D8PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
HYPROMELLOSE 2910 (3 MPA.S)INACTIVE INGREDIENT0VUT3PMY82PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]14
PAROXETINE HYDROCHLORIDEACTIVE INGREDIENT3I3T11UD2SPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
DIBASIC CALCIUM PHOSPHATE DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-157PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]23Current NDC, Legacy NDC, 5 package rows20250124_326e8ab0-6886-4749-9544-885b37070051.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738483PARoxetine HCl 10 MG Oral TabletPSN326e8ab0-6886-4749-9544-885b3707005124
1738495PARoxetine HCl 20 MG Oral TabletPSN326e8ab0-6886-4749-9544-885b3707005124
1738503PARoxetine HCl 30 MG Oral TabletPSN326e8ab0-6886-4749-9544-885b3707005124
1738511PARoxetine HCl 40 MG Oral TabletPSN326e8ab0-6886-4749-9544-885b3707005124
1738483paroxetine hydrochloride 10 MG Oral TabletSCD326e8ab0-6886-4749-9544-885b3707005124
1738495paroxetine hydrochloride 20 MG Oral TabletSCD326e8ab0-6886-4749-9544-885b3707005124
1738503paroxetine hydrochloride 30 MG Oral TabletSCD326e8ab0-6886-4749-9544-885b3707005124
1738511paroxetine hydrochloride 40 MG Oral TabletSCD326e8ab0-6886-4749-9544-885b3707005124
1738495PARoxetine HCl 20 MG Oral TabletPSN0a580de2-95d2-49b6-a1e2-6daf70f1f8c81
1738503PARoxetine HCl 30 MG Oral TabletPSN0a580de2-95d2-49b6-a1e2-6daf70f1f8c81
1738511PARoxetine HCl 40 MG Oral TabletPSN0a580de2-95d2-49b6-a1e2-6daf70f1f8c81
1738495paroxetine hydrochloride 20 MG Oral TabletSCD0a580de2-95d2-49b6-a1e2-6daf70f1f8c81
1738503paroxetine hydrochloride 30 MG Oral TabletSCD0a580de2-95d2-49b6-a1e2-6daf70f1f8c81
1738511paroxetine hydrochloride 40 MG Oral TabletSCD0a580de2-95d2-49b6-a1e2-6daf70f1f8c81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-157-0165862015701100 TABLET, FILM COATED in 1 BOTTLE (65862-157-01) 2007-07-250000-00-00NoNoCurrent
65862-157-0565862015705500 TABLET, FILM COATED in 1 BOTTLE (65862-157-05) 2007-07-250000-00-00NoNoCurrent
65862-157-306586201573030 TABLET, FILM COATED in 1 BOTTLE (65862-157-30) 2007-07-250000-00-00NoNoCurrent
65862-157-39658620157393000 TABLET, FILM COATED in 1 BAG (65862-157-39)25-JUL-07Current
65862-157-906586201579090 TABLET, FILM COATED in 1 BOTTLE (65862-157-90) 2007-07-250000-00-00NoNoCurrent
65862-157-99658620157991000 TABLET, FILM COATED in 1 BOTTLE (65862-157-99) 2007-07-250000-00-00NoNoCurrent