FDA.reportPublic FDA data

Paroxetine

Product NDC
62332-767
11-digit product format
623320767
Labeler code
62332
Product ID
62332-767_3646151d-201e-4bcb-aec9-95b266de2f9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Paroxetine
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA217280
Marketing category
ANDA
Marketing start
2025-09-30
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
2027-12-31
Current FDA listing
Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A217280-001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2025-09-24
A217280-002PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2025-09-24
A217280-003PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2026-03-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A217280-001AB
A217280-002AB
A217280-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A217280-001PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2025-09-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217280-002PAROXETINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2025-09-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217280-001PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2025-09-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217280-002PAROXETINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2025-09-2431067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217280-001PAROXETINE HYDROCHLORIDEEQ 25MG BASETABLET, EXTENDED RELEASE / ORALAB2025-09-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217280-002PAROXETINE HYDROCHLORIDEEQ 37.5MG BASETABLET, EXTENDED RELEASE / ORALAB2025-09-24a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217280-003PAROXETINE HYDROCHLORIDEEQ 12.5MG BASETABLET, EXTENDED RELEASE / ORALAB2026-03-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A217280-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A217280-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217280-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A217280-002AB131067a03dcf5…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217280-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217280-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A217280-003AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X2ELS050D8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1738803Internal RxNorm lookup
1738805Internal RxNorm lookup
1738807Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5da839f9-e2bf-4b83-a410-1226ba4552a1Available on FDA.report

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
62332-767-30Paroxetine30 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE305
62332-767-91Paroxetine1000 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE10005

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ParoxetinePAROXETINEAlembic Pharmaceuticals Limited59cb7de6-483d-4007-b6ef-f10a70b872e92026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217280
application number: ANDA217280
ParoxetinePAROXETINEAlembic Pharmaceuticals Inc.5da839f9-e2bf-4b83-a410-1226ba4552a12026-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 217280
application number: ANDA217280
ndc (product): 62332-767

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1738803PARoxetine HCl 12.5 MG 24HR Extended Release Oral TabletPSN5da839f9-e2bf-4b83-a410-1226ba4552a15
1738805PARoxetine HCl 25 MG 24HR Extended Release Oral TabletPSN5da839f9-e2bf-4b83-a410-1226ba4552a15
1738807PARoxetine HCl 37.5 MG 24HR Extended Release Oral TabletPSN5da839f9-e2bf-4b83-a410-1226ba4552a15
173880324 HR paroxetine hydrochloride 12.5 MG Extended Release Oral TabletSCD5da839f9-e2bf-4b83-a410-1226ba4552a15
173880524 HR paroxetine hydrochloride 25 MG Extended Release Oral TabletSCD5da839f9-e2bf-4b83-a410-1226ba4552a15
173880724 HR paroxetine hydrochloride 37.5 MG Extended Release Oral TabletSCD5da839f9-e2bf-4b83-a410-1226ba4552a15
1738803paroxetine hydrochloride 12.5 MG 24 HR Extended Release Oral TabletSY5da839f9-e2bf-4b83-a410-1226ba4552a15
1738805paroxetine hydrochloride 25 MG 24 HR Extended Release Oral TabletSY5da839f9-e2bf-4b83-a410-1226ba4552a15
1738807paroxetine hydrochloride 37.5 MG 24 HR Extended Release Oral TabletSY5da839f9-e2bf-4b83-a410-1226ba4552a15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
62332-767-306233207673030 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-767-30) 2025-09-30NoNoCurrent
62332-767-91623320767911000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (62332-767-91) 2025-09-30NoNoCurrent