Paroxetine

Product NDC: 68788-4130
11-digit product format: 687884130
Labeler code: 68788
Product ID: 68788-4130_1c2716c0-16e2-460d-8639-70d36f14714a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: paroxetine hydrochloride hemihydrate
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Preferred Pharmaceuticals Inc.
Application: ANDA203854
Marketing category: ANDA
Marketing start: 2026-09-28
Substance: PAROXETINE HYDROCHLORIDE
Active strength: 20 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 43.

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 · 172 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
2026-09-14 22:38:34	2026-08	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203854-001	PAROXETINE	EQ 10MG BASE	TABLET / ORAL	AB	2014-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203854-002	PAROXETINE	EQ 20MG BASE	TABLET / ORAL	AB	2014-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203854-003	PAROXETINE	EQ 30MG BASE	TABLET / ORAL	AB	2014-10-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203854-004	PAROXETINE	EQ 40MG BASE	TABLET / ORAL	AB	2014-10-31	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203854-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203854-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203854-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203854-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203854-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203854-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203854-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203854-004	AB	1	`caaa826d4ba7…`
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…`

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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PAROXETINE HYDROCHLORIDE	20 mg/1

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
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	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

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type	Form / route
1298842	paroxetine hydrochloride, hemihydrate	paroxetine hydrochloride, hemihydrate	PIN Active

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
68788-4130-1	68788413001	100 TABLET, FILM COATED in 1 BOTTLE (68788-4130-1)	2026-09-28	No	No	Current
68788-4130-3	68788413003	30 TABLET, FILM COATED in 1 BOTTLE (68788-4130-3)	2026-09-28	No	No	Current
68788-4130-6	68788413006	60 TABLET, FILM COATED in 1 BOTTLE (68788-4130-6)	2026-09-28	No	No	Current
68788-4130-8	68788413008	120 TABLET, FILM COATED in 1 BOTTLE (68788-4130-8)	2026-09-28	No	No	Current
68788-4130-9	68788413009	90 TABLET, FILM COATED in 1 BOTTLE (68788-4130-9)	2026-09-28	No	No	Current