FDA.reportPublic FDA data

Paroxetine

Product NDC
68382-001
11-digit product format
683820001
Labeler code
68382
Product ID
68382-001_c88d98d1-e370-4ad8-869a-603875f276cc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA077584
Marketing category
ANDA
Marketing start
2007-04-13
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
68382-001-01Paroxetine100 in 1 BOTTLETABLET, FILM COATED10016
68382-001-05Paroxetine500 in 1 BOTTLETABLET, FILM COATED50016
68382-001-06Paroxetine30 in 1 BOTTLETABLET, FILM COATED3016
68382-001-10Paroxetine1000 in 1 BOTTLETABLET, FILM COATED100016
68382-001-16Paroxetine90 in 1 BOTTLETABLET, FILM COATED9016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-001PAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]16Current NDC, Legacy NDC, 5 package rows20250112_a6bb4f0a-1555-4550-a7a4-99609674b1e7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738511PARoxetine HCl 40 MG Oral TabletPSNbc0efd3b-c6b9-4ed0-b517-6e57e4700b7b33
1738511paroxetine hydrochloride 40 MG Oral TabletSCDbc0efd3b-c6b9-4ed0-b517-6e57e4700b7b33
1738483PARoxetine HCl 10 MG Oral TabletPSNb5a8f864-a53d-48d9-aca6-6b64017fb16818
1738495PARoxetine HCl 20 MG Oral TabletPSNb5a8f864-a53d-48d9-aca6-6b64017fb16818
1738503PARoxetine HCl 30 MG Oral TabletPSNb5a8f864-a53d-48d9-aca6-6b64017fb16818
1738511PARoxetine HCl 40 MG Oral TabletPSNb5a8f864-a53d-48d9-aca6-6b64017fb16818
1738483paroxetine hydrochloride 10 MG Oral TabletSCDb5a8f864-a53d-48d9-aca6-6b64017fb16818
1738495paroxetine hydrochloride 20 MG Oral TabletSCDb5a8f864-a53d-48d9-aca6-6b64017fb16818
1738503paroxetine hydrochloride 30 MG Oral TabletSCDb5a8f864-a53d-48d9-aca6-6b64017fb16818
1738511paroxetine hydrochloride 40 MG Oral TabletSCDb5a8f864-a53d-48d9-aca6-6b64017fb16818
1738483PARoxetine HCl 10 MG Oral TabletPSNa6bb4f0a-1555-4550-a7a4-99609674b1e716
1738495PARoxetine HCl 20 MG Oral TabletPSNa6bb4f0a-1555-4550-a7a4-99609674b1e716
1738503PARoxetine HCl 30 MG Oral TabletPSNa6bb4f0a-1555-4550-a7a4-99609674b1e716
1738511PARoxetine HCl 40 MG Oral TabletPSNa6bb4f0a-1555-4550-a7a4-99609674b1e716
1738483paroxetine hydrochloride 10 MG Oral TabletSCDa6bb4f0a-1555-4550-a7a4-99609674b1e716
1738495paroxetine hydrochloride 20 MG Oral TabletSCDa6bb4f0a-1555-4550-a7a4-99609674b1e716
1738503paroxetine hydrochloride 30 MG Oral TabletSCDa6bb4f0a-1555-4550-a7a4-99609674b1e716
1738511paroxetine hydrochloride 40 MG Oral TabletSCDa6bb4f0a-1555-4550-a7a4-99609674b1e716
1738511PARoxetine HCl 40 MG Oral TabletPSN07f245c5-fcb0-3008-d69e-10290cadbfa69
1738511paroxetine hydrochloride 40 MG Oral TabletSCD07f245c5-fcb0-3008-d69e-10290cadbfa69
1738511PARoxetine HCl 40 MG Oral TabletPSN7d558598-6905-46da-8f34-668456c684118
1738511paroxetine hydrochloride 40 MG Oral TabletSCD7d558598-6905-46da-8f34-668456c684118
1738483PARoxetine HCl 10 MG Oral TabletPSN6318eefa-ee51-4e4e-91a5-8760d48bdc634
1738495PARoxetine HCl 20 MG Oral TabletPSN6318eefa-ee51-4e4e-91a5-8760d48bdc634
1738511PARoxetine HCl 40 MG Oral TabletPSN6318eefa-ee51-4e4e-91a5-8760d48bdc634
1738483paroxetine hydrochloride 10 MG Oral TabletSCD6318eefa-ee51-4e4e-91a5-8760d48bdc634
1738495paroxetine hydrochloride 20 MG Oral TabletSCD6318eefa-ee51-4e4e-91a5-8760d48bdc634
1738511paroxetine hydrochloride 40 MG Oral TabletSCD6318eefa-ee51-4e4e-91a5-8760d48bdc634
1738511PARoxetine HCl 40 MG Oral TabletPSN2cfe30fc-9c46-4efd-e054-00144ff8d46c3
1738511paroxetine hydrochloride 40 MG Oral TabletSCD2cfe30fc-9c46-4efd-e054-00144ff8d46c3
1738483PARoxetine HCl 10 MG Oral TabletPSN4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738495PARoxetine HCl 20 MG Oral TabletPSN4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738503PARoxetine HCl 30 MG Oral TabletPSN4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738511PARoxetine HCl 40 MG Oral TabletPSN4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738511PARoxetine HCl 40 MG Oral TabletPSN8e97c132-5740-adba-e053-2a95a90a094a2
1738483paroxetine hydrochloride 10 MG Oral TabletSCD4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738495paroxetine hydrochloride 20 MG Oral TabletSCD4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738503paroxetine hydrochloride 30 MG Oral TabletSCD4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738511paroxetine hydrochloride 40 MG Oral TabletSCD8e97c132-5740-adba-e053-2a95a90a094a2
1738511paroxetine hydrochloride 40 MG Oral TabletSCD4acd3e7a-4f19-4428-9452-48ce370cb3db2
1738483PARoxetine HCl 10 MG Oral TabletPSN32fd11aa-2996-496d-ac3b-76a6afe22e3c1
1738483PARoxetine HCl 10 MG Oral TabletPSN0d4fb45b-e45b-4519-96a3-a8a106450f871
1738495PARoxetine HCl 20 MG Oral TabletPSN0d4fb45b-e45b-4519-96a3-a8a106450f871
1738495PARoxetine HCl 20 MG Oral TabletPSN32fd11aa-2996-496d-ac3b-76a6afe22e3c1
1738503PARoxetine HCl 30 MG Oral TabletPSN32fd11aa-2996-496d-ac3b-76a6afe22e3c1
1738503PARoxetine HCl 30 MG Oral TabletPSN0d4fb45b-e45b-4519-96a3-a8a106450f871
1738511PARoxetine HCl 40 MG Oral TabletPSN32fd11aa-2996-496d-ac3b-76a6afe22e3c1
1738511PARoxetine HCl 40 MG Oral TabletPSN0d4fb45b-e45b-4519-96a3-a8a106450f871
1738483paroxetine hydrochloride 10 MG Oral TabletSCD32fd11aa-2996-496d-ac3b-76a6afe22e3c1
1738483paroxetine hydrochloride 10 MG Oral TabletSCD0d4fb45b-e45b-4519-96a3-a8a106450f871
1738495paroxetine hydrochloride 20 MG Oral TabletSCD0d4fb45b-e45b-4519-96a3-a8a106450f871
1738495paroxetine hydrochloride 20 MG Oral TabletSCD32fd11aa-2996-496d-ac3b-76a6afe22e3c1
1738503paroxetine hydrochloride 30 MG Oral TabletSCD0d4fb45b-e45b-4519-96a3-a8a106450f871
1738503paroxetine hydrochloride 30 MG Oral TabletSCD32fd11aa-2996-496d-ac3b-76a6afe22e3c1
1738511paroxetine hydrochloride 40 MG Oral TabletSCD32fd11aa-2996-496d-ac3b-76a6afe22e3c1
1738511paroxetine hydrochloride 40 MG Oral TabletSCD0d4fb45b-e45b-4519-96a3-a8a106450f871

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-001-0168382000101100 TABLET, FILM COATED in 1 BOTTLE (68382-001-01) 2007-04-130000-00-00NoNoCurrent
68382-001-0568382000105500 TABLET, FILM COATED in 1 BOTTLE (68382-001-05) 2007-04-130000-00-00NoNoCurrent
68382-001-066838200010630 TABLET, FILM COATED in 1 BOTTLE (68382-001-06) 2007-04-130000-00-00NoNoCurrent
68382-001-10683820001101000 TABLET, FILM COATED in 1 BOTTLE (68382-001-10) 2007-04-130000-00-00NoNoCurrent
68382-001-166838200011690 TABLET, FILM COATED in 1 BOTTLE (68382-001-16) 2007-04-130000-00-00NoNoCurrent