FDA.reportPublic FDA data

PAROXETINE HYDROCHLORIDE

Product NDC
31722-578
11-digit product format
317220578
Labeler code
31722
Product ID
31722-578_5092043a-0e8c-05e1-e063-6394a90ad3dc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PAROXETINE HYDROCHLORIDE
Dosage form
SUSPENSION
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA219954
Marketing category
ANDA
Marketing start
2026-03-05
Substance
PAROXETINE HYDROCHLORIDE
Active strength
10 mg/5mL
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 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A219954-001PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDEEQ 10MG BASE/5MLSUSPENSION / ORALAB2026-03-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A219954-001AB

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
2026-09-14 22:38:342026-08A219954-001PAROXETINE HYDROCHLORIDEEQ 10MG BASE/5MLSUSPENSION / ORALAB2026-03-0584e616aacf4f…
2026-08-18 06:07:402026-07A219954-001PAROXETINE HYDROCHLORIDEEQ 10MG BASE/5MLSUSPENSION / ORALAB2026-03-05caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219954-001PAROXETINE HYDROCHLORIDEEQ 10MG BASE/5MLSUSPENSION / ORALAB2026-03-05a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A219954-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A219954-001AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A219954-001AB1a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PAROXETINE HYDROCHLORIDE10 mg/5mL

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312242Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
26d37a39-1c53-461c-8834-c67fbffcfe99Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2ace441e-5ed1-9a56-64e5-302d887093bdProduct name720250107
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ba9fc237-0e76-4ac8-d3c5-cdb4df9e9f7fProduct name420220524
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
200c61bf-0879-1df7-72b7-b72a8497b114Product name320171006
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
b430fc19-562d-420b-53a2-64d42b938631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-578-25PAROXETINE HYDROCHLORIDE1 in 1 CARTONSUSPENSION11
31722-578-25PAROXETINE HYDROCHLORIDE250 mL in 1 BOTTLESUSPENSION2501

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAROXETINE HYDROCHLORIDEPAROXETINE HYDROCHLORIDECamber Pharmaceuticals, Inc.26d37a39-1c53-461c-8834-c67fbffcfe992026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 219954
application number: ANDA219954
ndc (product): 31722-578

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312242PARoxetine HCl 10 MG in 5 mL Oral SuspensionPSN26d37a39-1c53-461c-8834-c67fbffcfe991
312242paroxetine hydrochloride 2 MG/ML Oral SuspensionSCD26d37a39-1c53-461c-8834-c67fbffcfe991
312242paroxetine (as paroxetine hydrochloride) 10 MG per 5 ML Oral SuspensionSY26d37a39-1c53-461c-8834-c67fbffcfe991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-578-25317220578251 BOTTLE in 1 CARTON (31722-578-25) / 250 mL in 1 BOTTLE1 bottle2026-03-05NoNoCurrent