Paroxetine

Product NDC: 43547-350
11-digit product format: 435470350
Labeler code: 43547
Product ID: 43547-350_48f30016-3f81-4060-887c-6eaf14f17c1c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paroxetine hydrochloride hemihydrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Solco Healthcare US, LLC
Application: ANDA203854
Marketing category: ANDA
Marketing start: 2022-03-29
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

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A203854-001	PAROXETINE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31
A203854-002	PAROXETINE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31
A203854-003	PAROXETINE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31
A203854-004	PAROXETINE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
A203854-001	AB
A203854-002	AB
A203854-003	AB
A203854-004	AB

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A203854-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203854-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203854-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203854-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203854-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203854-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203854-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203854-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203854-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203854-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203854-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203854-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203854-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203854-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203854-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203854-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203854-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203854-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203854-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203854-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203854-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203854-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203854-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203854-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203854-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203854-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203854-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203854-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203854-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203854-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203854-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203854-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203854-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203854-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203854-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203854-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203854-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203854-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203854-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203854-004	AB	1	`d06236e962d9…`

Additional Listing Data#

Finished product: Yes
Brand name base: Paroxetine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PAROXETINE HYDROCHLORIDE HEMIHYDRATE	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X2ELS050D8	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1738483	Internal RxNorm lookup
1738495	Internal RxNorm lookup
1738503	Internal RxNorm lookup
1738511	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
6cfde064-ddcb-49df-a53c-953c40eb1470	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2ace441e-5ed1-9a56-64e5-302d887093bd	Product name	7	20250107
ba9fc237-0e76-4ac8-d3c5-cdb4df9e9f7f	Product name	4	20220524
200c61bf-0879-1df7-72b7-b72a8497b114	Product name	3	20171006
b430fc19-562d-420b-53a2-64d42b938631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43547-350-03	Paroxetine	30 in 1 BOTTLE	TABLET, FILM COATED	30	9
43547-350-09	Paroxetine	90 in 1 BOTTLE	TABLET, FILM COATED	90	9
43547-350-11	Paroxetine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	9
43547-350-50	Paroxetine	500 in 1 BOTTLE	TABLET, FILM COATED	500	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43547-350-03	EA - Each	43547-350	d900c485-a645-45e3-ba34-238e573d10ac	1	2015-01-05
43547-350-09	EA - Each	43547-350	3c2e2ae1-7836-4d58-93dc-5a15ef315464	1	2015-01-05
43547-350-11	EA - Each	43547-350	ea22f3f3-4747-47d2-8843-62f432a11ddb	1	2015-01-05
43547-350-50	EA - Each	43547-350	18ec2625-0fa5-4c03-8e42-b1de058c4929	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PAROXETINE HYDROCHLORIDE HEMIHYDRATE	ACTIVE INGREDIENT	X2ELS050D8	PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	1
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	1
GLYCERYL DIBEHENATE	INACTIVE INGREDIENT	R8WTH25YS2	PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43547-350	PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED [SOLCO HEALTHCARE US, LLC]	9	Current NDC, Legacy NDC, 4 package rows	20250124_6cfde064-ddcb-49df-a53c-953c40eb1470.zip

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	REMEDYREPACK INC.	88b4c469-19b3-44b9-a378-c7c3f4f436db	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	REMEDYREPACK INC.	4cb9dc05-adb8-4c88-ad40-af8c0df1cafd	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	REMEDYREPACK INC.	22174520-4b78-4841-96f7-530ba12d2cf1	2026-07-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	REMEDYREPACK INC.	90c129a8-afce-4b8b-85d7-f89e6da2aef7	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	REMEDYREPACK INC.	009d8b89-eab9-43ba-b077-86bfa993a745	2026-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	REMEDYREPACK INC.	28ddc9e0-05c5-482f-9371-60bbee451b33	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	NuCare Pharmaceuticals, Inc.	54efbbc1-4f5f-262d-e063-6394a90aadbc	2026-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	NuCare Pharmaceuticals, Inc.	49dd0858-685f-f46b-e063-6294a90a7f39	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	NuCare Pharmaceuticals, Inc.	34909bfb-b4ad-25c4-e063-6294a90a0296	2025-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	PD-Rx Pharmaceuticals, Inc.	d551f3d0-9503-45bd-b701-dfed4c8a5e1e	2025-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	PD-Rx Pharmaceuticals, Inc.	65c81817-34d3-4c57-a4bf-fb10be98386d	2025-02-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Preferred Pharmaceuticals Inc.	91c5a321-e174-4d86-9a84-e5e278d45aff	2025-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Solco Healthcare US, LLC	6cfde064-ddcb-49df-a53c-953c40eb1470	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854 ndc (product): 43547-350
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Bryant Ranch Prepack	ac6ea24f-a9f3-4413-8c3a-9e2e4ca93c0f	2024-06-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Proficient Rx LP	ce168c41-a860-45f5-bae8-7b3d9b48d86a	2024-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Proficient Rx LP	903e4ef1-487d-4b65-9038-b05ceaf74d19	2024-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	A-S Medication Solutions	525884d7-e2ee-4d57-a6c9-bd129e9fb9d0	2023-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	NCS HealthCare of KY, LLC dba Vangard Labs	c3b2ce88-6f09-4f7b-ac73-93dca84aa3b8	2022-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Proficient Rx LP	8526c68d-221c-4822-9532-1d7868cff35e	2022-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203854 application number: ANDA203854

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X2ELS050D8	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	110429-35-1	PAROXETINE HYDROCHLORIDE HEMIHYDRATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	ac6ea24f-a9f3-4413-8c3a-9e2e4ca93c0f	100
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	ac6ea24f-a9f3-4413-8c3a-9e2e4ca93c0f	100
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	60660c85-a49a-4043-99a2-97fc96318e5c	13
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	60660c85-a49a-4043-99a2-97fc96318e5c	13
1738503	PARoxetine HCl 30 MG Oral Tablet	PSN	60660c85-a49a-4043-99a2-97fc96318e5c	13
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	60660c85-a49a-4043-99a2-97fc96318e5c	13
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	22174520-4b78-4841-96f7-530ba12d2cf1	13
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	60660c85-a49a-4043-99a2-97fc96318e5c	13
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	60660c85-a49a-4043-99a2-97fc96318e5c	13
1738503	paroxetine hydrochloride 30 MG Oral Tablet	SCD	60660c85-a49a-4043-99a2-97fc96318e5c	13
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	22174520-4b78-4841-96f7-530ba12d2cf1	13
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	60660c85-a49a-4043-99a2-97fc96318e5c	13
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	6cfde064-ddcb-49df-a53c-953c40eb1470	9
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	6cfde064-ddcb-49df-a53c-953c40eb1470	9
1738503	PARoxetine HCl 30 MG Oral Tablet	PSN	6cfde064-ddcb-49df-a53c-953c40eb1470	9
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	6cfde064-ddcb-49df-a53c-953c40eb1470	9
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	65c81817-34d3-4c57-a4bf-fb10be98386d	9
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	6cfde064-ddcb-49df-a53c-953c40eb1470	9
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	6cfde064-ddcb-49df-a53c-953c40eb1470	9
1738503	paroxetine hydrochloride 30 MG Oral Tablet	SCD	6cfde064-ddcb-49df-a53c-953c40eb1470	9
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	6cfde064-ddcb-49df-a53c-953c40eb1470	9
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	65c81817-34d3-4c57-a4bf-fb10be98386d	9
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	c3b2ce88-6f09-4f7b-ac73-93dca84aa3b8	6
1738503	PARoxetine HCl 30 MG Oral Tablet	PSN	c3b2ce88-6f09-4f7b-ac73-93dca84aa3b8	6
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	c3b2ce88-6f09-4f7b-ac73-93dca84aa3b8	6
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	c3b2ce88-6f09-4f7b-ac73-93dca84aa3b8	6
1738503	paroxetine hydrochloride 30 MG Oral Tablet	SCD	c3b2ce88-6f09-4f7b-ac73-93dca84aa3b8	6
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	c3b2ce88-6f09-4f7b-ac73-93dca84aa3b8	6
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	903e4ef1-487d-4b65-9038-b05ceaf74d19	5
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	903e4ef1-487d-4b65-9038-b05ceaf74d19	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43547-350-03	43547035003	30 TABLET, FILM COATED in 1 BOTTLE (43547-350-03)	2022-03-29	0000-00-00	No	No	Current
43547-350-09	43547035009	90 TABLET, FILM COATED in 1 BOTTLE (43547-350-09)	2022-03-29	0000-00-00	No	No	Current
43547-350-11	43547035011	1000 TABLET, FILM COATED in 1 BOTTLE (43547-350-11)	2022-03-29	0000-00-00	No	No	Current
43547-350-50	43547035050	500 TABLET, FILM COATED in 1 BOTTLE (43547-350-50)	2022-03-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Paroxetine	REMEDYREPACK INC.	2026-07-20	HUMAN PRESCRIPTION DRUG LABEL	15
Paroxetine	PD-Rx Pharmaceuticals, Inc.	2025-02-19	HUMAN PRESCRIPTION DRUG LABEL	9
Paroxetine	Solco Healthcare US, LLC \| Prinston Pharmaceutical Inc. \| Zhejiang Huahai Pharmaceutical Co. Ltd \| Zhejiang Huahai Pharmaceutical Technology Co., Ltd.	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	9
Paroxetine Tablets USP, film coated for oral use	Bryant Ranch Prepack	2024-06-28	HUMAN PRESCRIPTION DRUG LABEL	100
Paroxetine Tablets USP, film coated for oral use	Proficient Rx LP	2024-05-01	HUMAN PRESCRIPTION DRUG LABEL	5
Paroxetine Tablets USP, film coated for oral use	NCS HealthCare of KY, LLC dba Vangard Labs	2022-09-02	HUMAN PRESCRIPTION DRUG LABEL	6
Paroxetine Tablets USP, film coated for oral use	Lake Erie Medical DBA Quality Care Products LLC	2022-08-29	HUMAN PRESCRIPTION DRUG LABEL	4
Paroxetine Tablets USP, film coated for oral use	Bryant Ranch Prepack	2020-09-18	HUMAN PRESCRIPTION DRUG LABEL	13
Paroxetine Tablets USP, film coated for oral use	REMEDYREPACK INC.	2019-08-21	HUMAN PRESCRIPTION DRUG LABEL	3