Paroxetine

Product NDC: 63187-105
11-digit product format: 631870105
Labeler code: 63187
Product ID: 63187-105_b0100eac-f51f-4aa9-88e1-f628aeea2412
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Paroxetine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA077584
Marketing category: ANDA
Marketing start: 2007-04-13
Substance: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength: 20 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
A077584-001	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-07
A077584-002	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-07
A077584-003	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-03-07
A077584-004	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-07

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077584-001	AB
A077584-002	AB
A077584-003	AB
A077584-004	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	A077584-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077584-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077584-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-03-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077584-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077584-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077584-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077584-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-03-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077584-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077584-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077584-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077584-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-03-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077584-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077584-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077584-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077584-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-03-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077584-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077584-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077584-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077584-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-03-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077584-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077584-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077584-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077584-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-03-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077584-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077584-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077584-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077584-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-03-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077584-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077584-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077584-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077584-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-03-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077584-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077584-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077584-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077584-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-03-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077584-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077584-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077584-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077584-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-03-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077584-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-07	`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	A077584-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077584-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077584-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077584-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077584-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077584-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077584-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077584-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077584-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077584-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077584-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077584-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077584-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077584-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077584-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077584-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077584-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077584-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077584-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077584-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077584-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077584-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077584-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077584-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077584-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077584-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077584-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077584-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077584-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077584-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077584-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077584-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077584-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077584-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077584-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077584-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077584-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077584-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077584-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077584-004	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	20 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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1738483	Internal RxNorm lookup
1738495	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
6318eefa-ee51-4e4e-91a5-8760d48bdc63	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
63187-105-30	Paroxetine	30 in 1 BOTTLE	TABLET, FILM COATED	30	4
63187-105-60	Paroxetine	60 in 1 BOTTLE	TABLET, FILM COATED	60	4
63187-105-90	Paroxetine	90 in 1 BOTTLE	TABLET, FILM COATED	90	4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PAROXETINE HYDROCHLORIDE HEMIHYDRATE	ACTIVE INGREDIENT	X2ELS050D8	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63187-105	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	4	Current NDC, Legacy NDC, 3 package rows	20210115_6318eefa-ee51-4e4e-91a5-8760d48bdc63.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 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paroxetine	PAROXETINE	REMEDYREPACK INC.	679e4b9b-0f7b-450a-aca7-1b448cccbeed	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	HAWAII REPACK, INC.	d5206418-aa7f-42dd-b977-4b9d1e4b2752	2026-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	American Health Packaging	b5a8f864-a53d-48d9-aca6-6b64017fb168	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	REMEDYREPACK INC.	05ec70fd-4c65-495f-ba12-e8433a10b655	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	REMEDYREPACK INC.	c002508e-f96c-413b-b232-5d55fceeffe0	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	REMEDYREPACK INC.	bc0efd3b-c6b9-4ed0-b517-6e57e4700b7b	2026-03-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
PAROXETINE	PAROXETINE	DIRECT RX	2cfe30fc-9c46-4efd-e054-00144ff8d46c	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	A-S Medication Solutions	31e4bb7c-59ab-4cbf-ba08-317c1417b28f	2026-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	A-S Medication Solutions	a809a6b5-18a3-4771-aaf8-7197d1743540	2026-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	NuCare Pharamceuticals, Inc.	49dc055c-faef-0be3-e063-6394a90a934f	2026-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	PD-Rx Pharmaceuticals, Inc.	c0acc97d-3d8d-4a7f-8acd-99050b0af2f1	2025-10-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	Preferred Pharmaceuticals Inc.	7d558598-6905-46da-8f34-668456c68411	2025-09-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE HYDROCHLORIDE	Preferred Pharmaceuticals, Inc	605c1d23-c97c-4ea4-92d0-fed351de9d2e	2025-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	Preferred Pharmaceuticals Inc.	ee38b589-e646-4203-bea5-cc3744fe17c3	2025-09-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	Bryant Ranch Prepack	0a0f8897-2099-4038-9b96-ed9c4f084018	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	Bryant Ranch Prepack	7a702760-9b72-4595-bf47-01aff786c74d	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	Bryant Ranch Prepack	07f245c5-fcb0-3008-d69e-10290cadbfa6	2025-03-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	Asclemed USA, Inc.	4acd3e7a-4f19-4428-9452-48ce370cb3db	2025-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	Direct_Rx	fea936a5-fdeb-e4fb-e053-6294a90a8995	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	Zydus Pharmaceuticals USA Inc.	a6bb4f0a-1555-4550-a7a4-99609674b1e7	2025-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X2ELS050D8	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	110429-35-1	PAROXETINE HYDROCHLORIDE HEMIHYDRATE
41VRH5220H	PAROXETINE	61869-08-7	Paroxetine

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	6318eefa-ee51-4e4e-91a5-8760d48bdc63	4
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	6318eefa-ee51-4e4e-91a5-8760d48bdc63	4
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	6318eefa-ee51-4e4e-91a5-8760d48bdc63	4
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	6318eefa-ee51-4e4e-91a5-8760d48bdc63	4
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	6318eefa-ee51-4e4e-91a5-8760d48bdc63	4
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	6318eefa-ee51-4e4e-91a5-8760d48bdc63	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63187-105-30	63187010530	30 TABLET, FILM COATED in 1 BOTTLE (63187-105-30)	2015-02-02	0000-00-00	No	No	Current
63187-105-60	63187010560	60 TABLET, FILM COATED in 1 BOTTLE (63187-105-60)	2015-02-02	0000-00-00	No	No	Current
63187-105-90	63187010590	90 TABLET, FILM COATED in 1 BOTTLE (63187-105-90)	2015-02-02	0000-00-00	No	No	Current