Paroxetine

Product NDC: 68382-097
11-digit product format: 683820097
Labeler code: 68382
Product ID: 68382-097_c88d98d1-e370-4ad8-869a-603875f276cc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Paroxetine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA077584
Marketing category: ANDA
Marketing start: 2007-04-13
Substance: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength: 10 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	10 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
a6bb4f0a-1555-4550-a7a4-99609674b1e7	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
68382-097-01	Paroxetine	100 in 1 BOTTLE	TABLET, FILM COATED	100	16
68382-097-05	Paroxetine	500 in 1 BOTTLE	TABLET, FILM COATED	500	16
68382-097-06	Paroxetine	30 in 1 BOTTLE	TABLET, FILM COATED	30	16
68382-097-10	Paroxetine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	16
68382-097-16	Paroxetine	90 in 1 BOTTLE	TABLET, FILM COATED	90	16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68382-097-01	EA - Each	68382-097	ce15ff3b-0bd9-431f-bd2a-215aa0c74fa4	1	2012-07-24
68382-097-05	EA - Each	68382-097	1ca17849-9688-4c80-b018-46308f3fd192	1	2012-07-24
68382-097-06	EA - Each	68382-097	fabf8f12-814b-4ca4-b595-0cde1cbea5a8	1	2012-07-24
68382-097-10	EA - Each	68382-097	3511289e-8a97-4657-b503-65a1b309b66f	1	2012-07-24
68382-097-16	EA - Each	68382-097	09a254b0-2929-49a7-b985-c8bd2d9b41c3	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PAROXETINE HYDROCHLORIDE HEMIHYDRATE	ACTIVE INGREDIENT	X2ELS050D8	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3198
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3198
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3198
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3198
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3198
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3198
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3198
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3198
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3198
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3198
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]	3198
PAROXETINE HYDROCHLORIDE HEMIHYDRATE	ACTIVE INGREDIENT	X2ELS050D8	PAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	19
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	19
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	19
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	PAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	19
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	19
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	19
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	PAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	19
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	19
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	19
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	19
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE TABLET, FILM COATED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]	19
PAROXETINE HYDROCHLORIDE HEMIHYDRATE	ACTIVE INGREDIENT	X2ELS050D8	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	7
PAROXETINE HYDROCHLORIDE HEMIHYDRATE	ACTIVE INGREDIENT	X2ELS050D8	PAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	6
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	6
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	PAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	6
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	PAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	6
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS (USA) INC.]	6
PAROXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	3I3T11UD2S	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
PAROXETINE HYDROCHLORIDE ANHYDROUS	ACTIVE INGREDIENT	3I3T11UD2S	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	2
PAROXETINE HYDROCHLORIDE HEMIHYDRATE	ACTIVE INGREDIENT	X2ELS050D8	PAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	2
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	2
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	2
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	PAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	2
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	PAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	2
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE TABLET, FILM COATED [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
PAROXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	3I3T11UD2S	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
PAROXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	3I3T11UD2S	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
PAROXETINE HYDROCHLORIDE HEMIHYDRATE	ACTIVE INGREDIENT	X2ELS050D8	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1
PAROXETINE HYDROCHLORIDE HEMIHYDRATE	ACTIVE INGREDIENT	X2ELS050D8	PAROXETINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	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 [AIDAREX PHARMACEUTICALS LLC]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1
HYPROMELLOSE 2910 (6 CPS)	INACTIVE INGREDIENT	0WZ8WG20P6	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
PEG-150 DISTEARATE	INACTIVE INGREDIENT	6F36Q0I0AC	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	PAROXETINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PAROXETINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	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 [AIDAREX PHARMACEUTICALS LLC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE TABLET, FILM COATED [PROFICIENT RX LP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CONTRACT PHARMACY SERVICES-PA]	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
68382-097	PAROXETINE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]	16	Current NDC, Legacy NDC, 5 package rows	20250112_a6bb4f0a-1555-4550-a7a4-99609674b1e7.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 ndc (product): 68382-097

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	7a702760-9b72-4595-bf47-01aff786c74d	103
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	7a702760-9b72-4595-bf47-01aff786c74d	103
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	b5a8f864-a53d-48d9-aca6-6b64017fb168	18
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	b5a8f864-a53d-48d9-aca6-6b64017fb168	18
1738503	PARoxetine HCl 30 MG Oral Tablet	PSN	b5a8f864-a53d-48d9-aca6-6b64017fb168	18
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	b5a8f864-a53d-48d9-aca6-6b64017fb168	18
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	b5a8f864-a53d-48d9-aca6-6b64017fb168	18
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	b5a8f864-a53d-48d9-aca6-6b64017fb168	18
1738503	paroxetine hydrochloride 30 MG Oral Tablet	SCD	b5a8f864-a53d-48d9-aca6-6b64017fb168	18
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	b5a8f864-a53d-48d9-aca6-6b64017fb168	18
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	a6bb4f0a-1555-4550-a7a4-99609674b1e7	16
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	a6bb4f0a-1555-4550-a7a4-99609674b1e7	16
1738503	PARoxetine HCl 30 MG Oral Tablet	PSN	a6bb4f0a-1555-4550-a7a4-99609674b1e7	16
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	a6bb4f0a-1555-4550-a7a4-99609674b1e7	16
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	a6bb4f0a-1555-4550-a7a4-99609674b1e7	16
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	a6bb4f0a-1555-4550-a7a4-99609674b1e7	16
1738503	paroxetine hydrochloride 30 MG Oral Tablet	SCD	a6bb4f0a-1555-4550-a7a4-99609674b1e7	16
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	a6bb4f0a-1555-4550-a7a4-99609674b1e7	16
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	605c1d23-c97c-4ea4-92d0-fed351de9d2e	11
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	605c1d23-c97c-4ea4-92d0-fed351de9d2e	11
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	605c1d23-c97c-4ea4-92d0-fed351de9d2e	11
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	605c1d23-c97c-4ea4-92d0-fed351de9d2e	11
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	31e4bb7c-59ab-4cbf-ba08-317c1417b28f	8
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	c002508e-f96c-413b-b232-5d55fceeffe0	8
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	31e4bb7c-59ab-4cbf-ba08-317c1417b28f	8
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	c002508e-f96c-413b-b232-5d55fceeffe0	8
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	570a9f0d-04fb-2922-e054-00144ff88e88	5
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	4f5c2c98-7936-4565-ac32-c432a7f2237e	5
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	570a9f0d-04fb-2922-e054-00144ff88e88	5
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	4f5c2c98-7936-4565-ac32-c432a7f2237e	5
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
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	4acd3e7a-4f19-4428-9452-48ce370cb3db	2
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	49dc055c-faef-0be3-e063-6394a90a934f	2
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	16348d76-055f-4a7a-9de9-00144c9ee339	2
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	fea936a5-fdeb-e4fb-e053-6294a90a8995	2
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	4acd3e7a-4f19-4428-9452-48ce370cb3db	2
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	16348d76-055f-4a7a-9de9-00144c9ee339	2
1738503	PARoxetine HCl 30 MG Oral Tablet	PSN	4acd3e7a-4f19-4428-9452-48ce370cb3db	2
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	4acd3e7a-4f19-4428-9452-48ce370cb3db	2
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	fea936a5-fdeb-e4fb-e053-6294a90a8995	2
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	4acd3e7a-4f19-4428-9452-48ce370cb3db	2
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	16348d76-055f-4a7a-9de9-00144c9ee339	2
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	49dc055c-faef-0be3-e063-6394a90a934f	2
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	4acd3e7a-4f19-4428-9452-48ce370cb3db	2
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	16348d76-055f-4a7a-9de9-00144c9ee339	2
1738503	paroxetine hydrochloride 30 MG Oral Tablet	SCD	4acd3e7a-4f19-4428-9452-48ce370cb3db	2
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	4acd3e7a-4f19-4428-9452-48ce370cb3db	2
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	32fd11aa-2996-496d-ac3b-76a6afe22e3c	1
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	0d4fb45b-e45b-4519-96a3-a8a106450f87	1
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	266a6a52-2889-11a6-e063-6394a90a7216	1
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	a03e69aa-3d6f-42fd-9cd1-9c1399bb5fa5	1
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	a03e69aa-3d6f-42fd-9cd1-9c1399bb5fa5	1
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	0d4fb45b-e45b-4519-96a3-a8a106450f87	1
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	32fd11aa-2996-496d-ac3b-76a6afe22e3c	1
1738503	PARoxetine HCl 30 MG Oral Tablet	PSN	0d4fb45b-e45b-4519-96a3-a8a106450f87	1
1738503	PARoxetine HCl 30 MG Oral Tablet	PSN	32fd11aa-2996-496d-ac3b-76a6afe22e3c	1
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	32fd11aa-2996-496d-ac3b-76a6afe22e3c	1
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	0d4fb45b-e45b-4519-96a3-a8a106450f87	1
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	266a6a52-2889-11a6-e063-6394a90a7216	1
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	0d4fb45b-e45b-4519-96a3-a8a106450f87	1
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	32fd11aa-2996-496d-ac3b-76a6afe22e3c	1
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	a03e69aa-3d6f-42fd-9cd1-9c1399bb5fa5	1
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	a03e69aa-3d6f-42fd-9cd1-9c1399bb5fa5	1
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	0d4fb45b-e45b-4519-96a3-a8a106450f87	1
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	32fd11aa-2996-496d-ac3b-76a6afe22e3c	1
1738503	paroxetine hydrochloride 30 MG Oral Tablet	SCD	32fd11aa-2996-496d-ac3b-76a6afe22e3c	1
1738503	paroxetine hydrochloride 30 MG Oral Tablet	SCD	0d4fb45b-e45b-4519-96a3-a8a106450f87	1
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	0d4fb45b-e45b-4519-96a3-a8a106450f87	1
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	32fd11aa-2996-496d-ac3b-76a6afe22e3c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68382-097-01	68382009701	100 TABLET, FILM COATED in 1 BOTTLE (68382-097-01)	2007-04-13	0000-00-00	No	No	Current
68382-097-05	68382009705	500 TABLET, FILM COATED in 1 BOTTLE (68382-097-05)	2007-04-13	0000-00-00	No	No	Current
68382-097-06	68382009706	30 TABLET, FILM COATED in 1 BOTTLE (68382-097-06)	2007-04-13	0000-00-00	No	No	Current
68382-097-10	68382009710	1000 TABLET, FILM COATED in 1 BOTTLE (68382-097-10)	2007-04-13	0000-00-00	No	No	Current
68382-097-16	68382009716	90 TABLET, FILM COATED in 1 BOTTLE (68382-097-16)	2007-04-13	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Paroxetine	HAWAII REPACK, INC.	2026-06-26	HUMAN PRESCRIPTION DRUG LABEL	1
Paroxetine	American Health Packaging	2026-05-13	HUMAN PRESCRIPTION DRUG LABEL	18
Paroxetine	REMEDYREPACK INC.	2026-04-09	HUMAN PRESCRIPTION DRUG LABEL	8
Paroxetine	A-S Medication Solutions	2026-02-20	HUMAN PRESCRIPTION DRUG LABEL	8
Paroxetine	NuCare Pharamceuticals, Inc.	2026-02-02	HUMAN PRESCRIPTION DRUG LABEL	2
Paroxetine	Preferred Pharmaceuticals, Inc	2025-09-05	HUMAN PRESCRIPTION DRUG LABEL	11
Paroxetine	Bryant Ranch Prepack	2025-03-28	HUMAN PRESCRIPTION DRUG LABEL	103
Paroxetine	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2025-03-05	HUMAN PRESCRIPTION DRUG LABEL	18
Paroxetine	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2025-02-13	HUMAN PRESCRIPTION DRUG LABEL	2
Paroxetine	Direct_Rx	2025-01-22	HUMAN PRESCRIPTION DRUG LABEL	2
Paroxetine	Zydus Pharmaceuticals USA Inc. \| Zydus Lifesciences Limited	2025-01-07	HUMAN PRESCRIPTION DRUG LABEL	16
Paroxetine	Coupler LLC \| Zydus Pharmaceuticals USA Inc.	2024-11-08	HUMAN PRESCRIPTION DRUG LABEL	1
Paroxetine Tablets, USP	NuCare Pharmaceuticals,Inc.	2024-07-15	HUMAN PRESCRIPTION DRUG LABEL	5
Paroxetine	REMEDYREPACK INC.	2022-03-10	HUMAN PRESCRIPTION DRUG LABEL	6
Paroxetine Tablets, USP	Lake Erie Medical DBA Quality Care Products LLC	2022-02-22	HUMAN PRESCRIPTION DRUG LABEL	3202
Paroxetine Tablets, USP	McKesson Corporation dba RX Pak	2021-02-10	HUMAN PRESCRIPTION DRUG LABEL	5
Paroxetine Tablets, USP	Proficient Rx LP	2021-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Paroxetine Tablets, USP	REMEDYREPACK INC.	2019-07-08	HUMAN PRESCRIPTION DRUG LABEL	1
Paroxetine Tablets, USP	TYA Pharmaceuticals	2014-08-05	HUMAN PRESCRIPTION DRUG LABEL	5
Paroxetine Tablets, USP	Aidarex Pharmaceuticals LLC	2014-01-23	HUMAN PRESCRIPTION DRUG LABEL	1
Paroxetine	NCS HealthCare of KY, Inc dba Vangard Labs	2013-12-23	HUMAN PRESCRIPTION DRUG LABEL	19
Paroxetine Tablets, USP	H.J. Harkins Company, Inc. \| Zydus Pharmaceuticals (USA) Inc. \| Cadila Healthcare Limited	2011-12-29	HUMAN PRESCRIPTION DRUG LABEL	2