Paroxetine

Product NDC: 65862-154
Requested package NDC: 65862-154-59
11-digit product format: 658620154
Labeler code: 65862
Product ID: 65862-154_19f7a08f-58bd-45b8-a750-4432ae161455
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Paroxetine Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA078406
Marketing category: ANDA
Marketing start: 2007-07-25
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
unfinished package	package	65862-154	65862-154-59	UNFINISHED	Active or certified unfinished drug listing		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 21 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 21:27 UTC · source 2025-12-05	`a6255e0c9aa5…`	`a0211a219f2e…`
2025-08-26 23:59 UTC · source 2025-08-26	`1d862106b807…`	`00c93037cd84…`
2025-05-15 14:59 UTC · source 2025-05-14	`390b4c401c3f…`	`2c692c2daee3…`
2025-04-01 07:37 UTC · source 2025-03-31	`e30019b0c005…`	`a3f0b14938b7…`
2025-03-01 13:19 UTC · source 2025-02-28	`bbbc9f937eca…`	`946b9c97cf81…`
2025-02-27 05:24 UTC · source 2025-02-26	`f268b84574a6…`	`26285f5ac5df…`
2025-02-01 13:13 UTC · source 2025-01-31	`f764e8902f78…`	`92046438deef…`
2025-01-20 13:05 UTC · source 2025-01-17	`68b1e3bced9e…`	`98a755eb8bc6…`
2024-11-29 20:42 UTC · source 2024-11-29	`05c55d027831…`	`ca05dca9dc4c…`
2024-11-09 02:36 UTC · source 2024-11-08	`48b4f40e6753…`	`c7c7a00d2afa…`
2024-10-09 02:27 UTC · source 2024-10-08	`27f29a85d7e4…`	`1372111e901f…`
2024-07-10 04:00 UTC · source 2024-07-09	`8d62ce987f31…`	`9fe9ef23e30d…`
2024-05-28 21:11 UTC · source 2024-05-28	`d1e113ab4d42…`	`063ee3eb0a1d…`
2024-05-15 03:51 UTC · source 2024-05-14	`50b4072663b7…`	`eae3003ed65e…`
2022-04-09 23:13 UTC · source 2022-04-08	`906f6e251498…`	`bf70b80e44f0…`
2021-12-27 23:28 UTC · source 2021-12-27	`6db9cb8d1e19…`	`3449e1ec5b70…`
2021-02-18 23:40 UTC · source 2021-02-18	`8fc7167e32ce…`	`e96bbc724034…`
2020-12-18 03:04 UTC · source 2020-12-17	`4184dd79f89f…`	`545327b3e20f…`
2020-06-10 20:45 UTC · source 2020-06-10	`4bd3596a7b87…`	`5c64c6f6865f…`
2019-12-08 06:16 UTC · source 2019-12-05	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	`5b2001dcd8f5…`	`54b53d4dc9e4…`

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
A078406-001	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-25
A078406-002	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-07-25
A078406-003	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-07-25
A078406-004	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-07-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078406-001	AB
A078406-002	AB
A078406-003	AB
A078406-004	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	A078406-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078406-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078406-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078406-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-07-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078406-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078406-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078406-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078406-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-07-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078406-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078406-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078406-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078406-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-07-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078406-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078406-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078406-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078406-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-07-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078406-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078406-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078406-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078406-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-07-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078406-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078406-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078406-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078406-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-07-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078406-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078406-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078406-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078406-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-07-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078406-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078406-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078406-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078406-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-07-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078406-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078406-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078406-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078406-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-07-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078406-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078406-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078406-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078406-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-07-25	`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	A078406-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078406-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078406-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078406-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078406-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078406-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078406-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078406-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078406-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078406-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078406-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078406-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078406-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078406-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078406-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078406-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078406-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078406-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078406-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078406-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078406-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078406-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078406-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078406-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078406-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078406-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078406-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078406-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078406-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078406-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078406-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078406-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078406-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078406-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078406-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078406-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078406-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078406-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078406-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078406-004	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
326e8ab0-6886-4749-9544-885b37070051	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
65862-154-01	Paroxetine	100 in 1 BOTTLE	TABLET, FILM COATED	100	24
65862-154-05	Paroxetine	500 in 1 BOTTLE	TABLET, FILM COATED	500	24
65862-154-30	Paroxetine	30 in 1 BOTTLE	TABLET, FILM COATED	30	24
65862-154-90	Paroxetine	90 in 1 BOTTLE	TABLET, FILM COATED	90	24
65862-154-99	Paroxetine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	24

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65862-154-30	EA - Each	65862-154	aef0e334-2468-4aa7-b28d-6a058ef392ed	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 [AUROBINDO PHARMA LIMITED]	14
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	14
PAROXETINE HYDROCHLORIDE HEMIHYDRATE	ACTIVE INGREDIENT	X2ELS050D8	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]	4
PAROXETINE HYDROCHLORIDE HEMIHYDRATE	ACTIVE INGREDIENT	X2ELS050D8	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]	1
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]	1
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]	1
DIBASIC CALCIUM PHOSPHATE DIHYDRATE	INACTIVE INGREDIENT	O7TSZ97GEP	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]	1
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65862-154	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	23	Current NDC, Legacy NDC, 5 package rows	20250124_326e8ab0-6886-4749-9544-885b37070051.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paroxetine	PAROXETINE	REMEDYREPACK INC.	f52ca1fc-fbf7-4b2b-9e74-975c310b8ce6	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078406 application number: ANDA078406
Paroxetine	PAROXETINE HYDROCHLORIDE	NorthStar Rx LLC	118320de-0632-4139-8b13-7428b41da0ac	2026-07-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078406 application number: ANDA078406
Paroxetine	PAROXETINE	AvPAK	d9a5e0aa-e638-5d6e-75c2-20cb78fc4f43	2026-03-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078406 application number: ANDA078406
Paroxetine	PAROXETINE	Aurolife Pharma LLC	e1ea4019-bb66-403c-a3d5-6ae056a59116	2025-06-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078406 application number: ANDA078406
Paroxetine	PAROXETINE HYDROCHLORIDE	Aurobindo Pharma Limited	326e8ab0-6886-4749-9544-885b37070051	2025-05-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078406 application number: ANDA078406 ndc (product): 65862-154
Paroxetine	PAROXETINE	NCS HealthCare of KY, LLC dba Vangard Labs	0a8a58c7-5008-4c65-ae0e-e4ee809b1807	2022-09-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078406 application number: ANDA078406
Paroxetine	PAROXETINE	Proficient Rx LP	847118ec-c139-466c-834b-1ae0b6e1f791	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078406 application number: ANDA078406
Paroxetine	PAROXETINE	Aphena Pharma Solutions - Tennessee, LLC	662223ec-3b9b-4a85-9680-789522363a7b	2018-07-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078406 application number: ANDA078406
Paroxetine	PAROXETINE	Aphena Pharma Solutions - Tennessee, LLC	30fd2fc4-f661-44c9-a9a9-9d0de0892e3c	2018-05-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078406 application number: ANDA078406

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	326e8ab0-6886-4749-9544-885b37070051	24
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	326e8ab0-6886-4749-9544-885b37070051	24
1738503	PARoxetine HCl 30 MG Oral Tablet	PSN	326e8ab0-6886-4749-9544-885b37070051	24
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	326e8ab0-6886-4749-9544-885b37070051	24
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	326e8ab0-6886-4749-9544-885b37070051	24
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	326e8ab0-6886-4749-9544-885b37070051	24
1738503	paroxetine hydrochloride 30 MG Oral Tablet	SCD	326e8ab0-6886-4749-9544-885b37070051	24
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	326e8ab0-6886-4749-9544-885b37070051	24
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	695bc7cc-ae91-4190-b5d6-94295d668673	1
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	695bc7cc-ae91-4190-b5d6-94295d668673	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Status
65862-154-59	65862015459	5000 TABLET, FILM COATED in 1 BAG (65862-154-59)	25-JUL-07	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Paroxetine	Aurobindo Pharma Limited	2025-05-15	Human Prescription Drug Label	24
Paroxetine Tablets, USP Rx only	Preferred Pharmaceuticals, Inc.	2019-02-08	HUMAN PRESCRIPTION DRUG LABEL	7
Paroxetine Tablets, USP	STAT Rx USA LLC \| PSS World Medical Inc.	2012-09-28	Human Prescription Drug Label	1