Paroxetine

Product NDC: 70954-319
11-digit product format: 709540319
Labeler code: 70954
Product ID: 70954-319_367bb2bf-beef-4f9a-b045-0c23e9021701
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Paroxetine
Dosage form: SUSPENSION
Route: ORAL
Labeler: ANI Pharmaceuticals, Inc.
Application: ANDA215003
Marketing category: ANDA
Marketing start: 2021-09-03
Substance: PAROXETINE HYDROCHLORIDE HEMIHYDRATE
Active strength: 10 mg/5mL
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215003-001	PAROXETINE HYDROCHLORIDE	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RS	2021-09-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215003-001	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RS	2021-09-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RS	2021-09-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RS	2021-09-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RS	2021-09-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RS	2021-09-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RS	2021-09-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL		RS	2021-09-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB		2021-09-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215003-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE/5ML	SUSPENSION / ORAL	AB	RS	2021-09-03	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215003-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215003-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215003-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215003-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215003-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215003-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215003-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215003-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215003-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215003-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215003-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215003-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215003-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215003-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215003-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215003-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215003-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215003-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215003-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215003-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215003-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215003-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215003-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215003-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215003-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215003-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215003-001	CGT	2022-03-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215003-001	CGT	2022-03-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215003-001	CGT	2022-03-12	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215003-001	CGT	2022-03-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215003-001	CGT	2022-03-12	`782e0a99824c…`
2023-01-26 05:58 UTC	2023-01	A215003-001	CGT	2022-03-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215003-001	CGT	2022-03-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215003-001	CGT	2022-03-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215003-001	CGT	2022-03-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215003-001	CGT	2022-03-12	`cb3db0bc1861…`

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/5mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312242	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
134e76f0-45cf-47eb-b6e1-cdb3bb522a0a	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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
ba9fc237-0e76-4ac8-d3c5-cdb4df9e9f7f	Product name	4	20220524
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906	Product name	7	20210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
200c61bf-0879-1df7-72b7-b72a8497b114	Product name	3	20171006
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
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
70954-319-10	Paroxetine	250 mL in 1 BOTTLE	SUSPENSION	250		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70954-319-10	ML - Milliliter	70954-319	47bd0ef5-1130-4b61-94a4-296fc1017ab0	1	2021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70954-319	PAROXETINE SUSPENSION [ANI PHARMACEUTICALS, INC.]	5	Current NDC, Legacy NDC, 1 package rows	20250429_134e76f0-45cf-47eb-b6e1-cdb3bb522a0a.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Paroxetine	PAROXETINE	ANI Pharmaceuticals, Inc.	134e76f0-45cf-47eb-b6e1-cdb3bb522a0a	2024-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215003 application number: ANDA215003 ndc (product): 70954-319

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
312242	PARoxetine HCl 10 MG in 5 mL Oral Suspension	PSN	134e76f0-45cf-47eb-b6e1-cdb3bb522a0a	5
312242	paroxetine hydrochloride 2 MG/ML Oral Suspension	SCD	134e76f0-45cf-47eb-b6e1-cdb3bb522a0a	5
312242	paroxetine (as paroxetine hydrochloride) 10 MG per 5 ML Oral Suspension	SY	134e76f0-45cf-47eb-b6e1-cdb3bb522a0a	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70954-319-10	70954031910	250 mL in 1 BOTTLE (70954-319-10)	250 ml	2021-09-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Paroxetine	ANI Pharmaceuticals, Inc. \| Novitium Pharma LLC	2024-09-16	Human Prescription Drug Label	5