Paroxetine

Product NDC: 68084-044
11-digit product format: 680840044
Labeler code: 68084
Product ID: 68084-044_51b97a0a-6710-bf64-e063-6294a90ae626
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Paroxetine
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: American Health Packaging
Application: ANDA077584
Marketing category: ANDA
Marketing start: 2005-03-15
Substance: PAROXETINE HYDROCHLORIDE
Active strength: 10 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
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 · 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	A077584-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077584-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077584-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-03-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077584-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077584-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077584-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077584-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-03-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077584-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-07	`caaa826d4ba7…`
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…`

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	A077584-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077584-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077584-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A077584-004	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077584-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077584-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077584-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A077584-004	AB	1	`caaa826d4ba7…`
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…`

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	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
b5a8f864-a53d-48d9-aca6-6b64017fb168	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
68084-044-01	Paroxetine	100 in 1 BOX, UNIT-DOSE	TABLET, FILM COATED	100	18
68084-044-11	Paroxetine	1 in 1 BLISTER PACK	TABLET, FILM COATED	1	18
68084-044-65	Paroxetine	50 in 1 CARTON	TABLET, FILM COATED	50	18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68084-044-01	EA - Each	68084-044	d54bd753-ee73-4446-b628-b9ca76aaa95e	1	2012-07-24
68084-044-11	EA - Each	68084-044	a52f8ffc-d53e-4f32-9d49-7d7ca7b307c2	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 [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 (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]	6
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]	6
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]	6
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]	6
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]	6
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]	6
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]	6
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [CARDINAL HEALTH]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68084-044	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]	15	Current NDC, Legacy NDC, 3 package rows	20240504_b5a8f864-a53d-48d9-aca6-6b64017fb168.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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Paroxetine	PAROXETINE	Advanced Rx Pharmacy of Tennessee, LLC	fc11a056-7db5-1966-e053-6394a90aa59c	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE HYDROCHLORIDE	Zydus Lifesciences Limited	6d5fcdb2-4d84-4b20-87e3-58a43e567500	2024-12-03		Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	Bryant Ranch Prepack	40dcf270-64bb-bca0-db08-6b233a3430f8	2024-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	NuCare Pharmaceuticals,Inc.	570a9f0d-04fb-2922-e054-00144ff88e88	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 077584 application number: ANDA077584
Paroxetine	PAROXETINE	Proficient Rx LP	6318eefa-ee51-4e4e-91a5-8760d48bdc63	2021-01-01	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
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	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68084-044-01	68084004401	100 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-044-01) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-044-11)	100 blister pack	2005-03-15	0000-00-00	No	No	Current
68084-044-11	68084004411	1 in 1 BLISTER PACK						Historical
68084-044-65	68084004465	50 BLISTER PACK in 1 CARTON (68084-044-65) / 1 TABLET, FILM COATED in 1 BLISTER PACK (68084-044-11)	50 blister pack	2026-05-13		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Paroxetine	American Health Packaging	2026-05-13	HUMAN PRESCRIPTION DRUG LABEL	18
Paroxetine Tablets, USP 8004401/1117 Rx only	Cardinal Health	2020-06-15	HUMAN PRESCRIPTION DRUG LABEL	11