PAROXETINE

Product NDC: 42858-703
11-digit product format: 428580703
Labeler code: 42858
Product ID: 42858-703_9182de9d-25d0-4d69-b59a-af086213cd4f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Dosage form: TABLET, FILM COATED, EXTENDED RELEASE
Route: ORAL
Labeler: Rhodes Pharmaceuticals LLC
Application: ANDA209293
Marketing category: ANDA
Marketing start: 2018-09-14
Marketing end: 2026-07-31
Substance: PAROXETINE HYDROCHLORIDE
Active strength: 12.5 mg/1
Pharmacologic classes: Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag: No
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	42858-703		D	Discontinued by firm	2026-08-03
excluded package	package	42858-703	42858-703-03	D	Discontinued by firm	2026-08-03
excluded package	package	42858-703	42858-703-50	D	Discontinued by firm	2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A209293-001	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12
A209293-002	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12
A209293-003	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A209293-001	AB
A209293-002	AB
A209293-003	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 4 · 123 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	A209293-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209293-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209293-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209293-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209293-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209293-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209293-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209293-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209293-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209293-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209293-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209293-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209293-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209293-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209293-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209293-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209293-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209293-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209293-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209293-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209293-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209293-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209293-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209293-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209293-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209293-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209293-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209293-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209293-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209293-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209293-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209293-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209293-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209293-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209293-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209293-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209293-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209293-002	PAROXETINE HYDROCHLORIDE	EQ 25MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209293-003	PAROXETINE HYDROCHLORIDE	EQ 37.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209293-001	PAROXETINE HYDROCHLORIDE	EQ 12.5MG BASE	TABLET, EXTENDED RELEASE / ORAL	AB	2018-06-12	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A209293-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209293-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209293-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209293-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209293-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209293-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209293-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209293-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209293-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209293-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209293-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209293-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209293-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209293-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209293-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209293-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209293-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209293-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209293-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209293-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209293-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209293-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209293-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209293-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209293-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209293-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209293-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209293-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209293-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209293-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209293-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209293-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209293-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209293-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209293-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209293-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209293-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209293-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209293-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209293-001	AB	1	`8072bd15b7f6…`

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	Strength	SPL version
42858-703-03	PAROXETINE	30 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	30		9
42858-703-50	PAROXETINE	500 in 1 BOTTLE	TABLET, FILM COATED, EXTENDED RE	500		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42858-703-03	EA - Each	42858-703	2b02e925-c54a-47d6-a423-06d7347d9160	1	2018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42858-703	PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) TABLET, FILM COATED, EXTENDED RELEASE [RHODES PHARMACEUTICALS L.P.]	7	Current NDC, Legacy NDC, 2 package rows	20240614_f562ab1a-adb9-4154-81cd-ceb480234331.zip

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
1738803	PARoxetine HCl 12.5 MG 24HR Extended Release Oral Tablet	PSN	27729943-8046-4342-af60-bc1da229abac	104
1738803	24 HR paroxetine hydrochloride 12.5 MG Extended Release Oral Tablet	SCD	27729943-8046-4342-af60-bc1da229abac	104
1738803	paroxetine hydrochloride 12.5 MG 24 HR Extended Release Oral Tablet	SY	27729943-8046-4342-af60-bc1da229abac	104
1738803	PARoxetine HCl 12.5 MG 24HR Extended Release Oral Tablet	PSN	f562ab1a-adb9-4154-81cd-ceb480234331	9
1738805	PARoxetine HCl 25 MG 24HR Extended Release Oral Tablet	PSN	f562ab1a-adb9-4154-81cd-ceb480234331	9
1738807	PARoxetine HCl 37.5 MG 24HR Extended Release Oral Tablet	PSN	f562ab1a-adb9-4154-81cd-ceb480234331	9
1738803	24 HR paroxetine hydrochloride 12.5 MG Extended Release Oral Tablet	SCD	f562ab1a-adb9-4154-81cd-ceb480234331	9
1738805	24 HR paroxetine hydrochloride 25 MG Extended Release Oral Tablet	SCD	f562ab1a-adb9-4154-81cd-ceb480234331	9
1738807	24 HR paroxetine hydrochloride 37.5 MG Extended Release Oral Tablet	SCD	f562ab1a-adb9-4154-81cd-ceb480234331	9
1738803	paroxetine hydrochloride 12.5 MG 24 HR Extended Release Oral Tablet	SY	f562ab1a-adb9-4154-81cd-ceb480234331	9
1738805	paroxetine hydrochloride 25 MG 24 HR Extended Release Oral Tablet	SY	f562ab1a-adb9-4154-81cd-ceb480234331	9
1738807	paroxetine hydrochloride 37.5 MG 24 HR Extended Release Oral Tablet	SY	f562ab1a-adb9-4154-81cd-ceb480234331	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
42858-703-03	42858070303	30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42858-703-03)	2018-09-14	2026-07-31	No	No	Current
42858-703-50	42858070350	500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (42858-703-50)	2018-09-14	2026-07-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PAROXETINE	Rhodes Pharmaceuticals LLC \| Quotient Sciences-Philadelphia, LLC \| Beijing Sciecure Pharmaceutical Co., Ltd.	2026-05-26	HUMAN PRESCRIPTION DRUG LABEL	9
PAROXETINE	Bryant Ranch Prepack	2025-07-08	HUMAN PRESCRIPTION DRUG LABEL	104