Paroxetine Tablets, USP

Manufacturer: Zydus Lifesciences Limited
Effective date: 2024-12-03
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 13
Source: full-release
Hydrated at: 2026-05-31 21:18:51

Label at a glance#

ProductParoxetine

Active ingredientPAROXETINE HYDROCHLORIDE ANHYDROUS

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-097-06 in pack count of 30 tablets

Paroxetine Tablets USP, 10 mg

R_xonly

30 tablets

NDC 65841-098-06 in pack count of 30 tablets

Paroxetine Tablets USP, 20 mg

R_xonly

30 tablets

NDC 65841-099-06 in pack count of 30 tablets

Paroxetine Tablets USP, 30 mg

R_xonly

30 tablets

NDC 65841-601-06 in pack count of 30 tablets

Paroxetine Tablets USP, 40 mg

R_xonly

30 tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1738483	PARoxetine HCl 10 MG Oral Tablet	PSN	13
1738495	PARoxetine HCl 20 MG Oral Tablet	PSN	13
1738503	PARoxetine HCl 30 MG Oral Tablet	PSN	13
1738511	PARoxetine HCl 40 MG Oral Tablet	PSN	13
1738483	paroxetine hydrochloride 10 MG Oral Tablet	SCD	13
1738495	paroxetine hydrochloride 20 MG Oral Tablet	SCD	13
1738503	paroxetine hydrochloride 30 MG Oral Tablet	SCD	13
1738511	paroxetine hydrochloride 40 MG Oral Tablet	SCD	13

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
PAROXETINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
65841-097-01	Paroxetine	100 in 1 BOTTLE	TABLET, FILM COATED	100	13
65841-097-05	Paroxetine	500 in 1 BOTTLE	TABLET, FILM COATED	500	13
65841-097-06	Paroxetine	30 in 1 BOTTLE	TABLET, FILM COATED	30	13
65841-097-10	Paroxetine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	13
65841-097-16	Paroxetine	90 in 1 BOTTLE	TABLET, FILM COATED	90	13
65841-098-01	Paroxetine	100 in 1 BOTTLE	TABLET, FILM COATED	100	13
65841-098-05	Paroxetine	500 in 1 BOTTLE	TABLET, FILM COATED	500	13
65841-098-06	Paroxetine	30 in 1 BOTTLE	TABLET, FILM COATED	30	13
65841-098-10	Paroxetine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	13
65841-098-16	Paroxetine	90 in 1 BOTTLE	TABLET, FILM COATED	90	13
65841-099-01	Paroxetine	100 in 1 BOTTLE	TABLET, FILM COATED	100	13
65841-099-05	Paroxetine	500 in 1 BOTTLE	TABLET, FILM COATED	500	13
65841-099-06	Paroxetine	30 in 1 BOTTLE	TABLET, FILM COATED	30	13
65841-099-10	Paroxetine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	13
65841-099-16	Paroxetine	90 in 1 BOTTLE	TABLET, FILM COATED	90	13
65841-601-01	Paroxetine	100 in 1 BOTTLE	TABLET, FILM COATED	100	13
65841-601-05	Paroxetine	500 in 1 BOTTLE	TABLET, FILM COATED	500	13
65841-601-06	Paroxetine	30 in 1 BOTTLE	TABLET, FILM COATED	30	13
65841-601-10	Paroxetine	1000 in 1 BOTTLE	TABLET, FILM COATED	1000	13
65841-601-16	Paroxetine	90 in 1 BOTTLE	TABLET, FILM COATED	90	13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65841-097	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	13	Current NDC, Legacy NDC, 5 package rows	20241207_6d5fcdb2-4d84-4b20-87e3-58a43e567500.zip
65841-098	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	13	Current NDC, Legacy NDC, 5 package rows	20241207_6d5fcdb2-4d84-4b20-87e3-58a43e567500.zip
65841-099	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	13	Current NDC, Legacy NDC, 5 package rows	20241207_6d5fcdb2-4d84-4b20-87e3-58a43e567500.zip
65841-601	PAROXETINE (PAROXETINE HYDROCHLORIDE) TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]	13	Current NDC, Legacy NDC, 5 package rows	20241207_6d5fcdb2-4d84-4b20-87e3-58a43e567500.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
PAROXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	3I3T11UD2S	4
PAROXETINE	ACTIVE MOIETY	41VRH5220H	4
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	4
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	4
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	4
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	4
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	4
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	4

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

Paroxetine
Paroxetine Hydrochloride
PAROXETINE HYDROCHLORIDE ANHYDROUS
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
ANHYDROUS LACTOSE
HYPROMELLOSES
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 6000
SODIUM STARCH GLYCOLATE TYPE A POTATO
POVIDONE
TALC
TITANIUM DIOXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65841-097	65841-097-06, 65841-097-16, 65841-097-01, 65841-097-05, 65841-097-10
65841-098	65841-098-06, 65841-098-16, 65841-098-01, 65841-098-05, 65841-098-10
65841-099	65841-099-06, 65841-099-16, 65841-099-01, 65841-099-05, 65841-099-10
65841-601	65841-601-06, 65841-601-16, 65841-601-01, 65841-601-05, 65841-601-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
PAROXETINE HYDROCHLORIDE ANHYDROUS	3I3T11UD2S	ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
POVIDONE	FZ989GH94E	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
PAROXETINE HYDROCHLORIDE ANHYDROUS	3I3T11UD2S	ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
POVIDONE	FZ989GH94E	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
PAROXETINE HYDROCHLORIDE ANHYDROUS	3I3T11UD2S	ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
POVIDONE	FZ989GH94E	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
PAROXETINE HYDROCHLORIDE ANHYDROUS	3I3T11UD2S	ACTIM
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	IACT
ANHYDROUS LACTOSE	3SY5LH9PMK	IACT
HYPROMELLOSES	3NXW29V3WO	IACT
MAGNESIUM STEARATE	70097M6I30	IACT
POLYETHYLENE GLYCOL 6000	30IQX730WE	IACT
SODIUM STARCH GLYCOLATE TYPE A POTATO	5856J3G2A2	IACT
POVIDONE	FZ989GH94E	IACT
TALC	7SEV7J4R1U	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 192 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, FILM COATED / ORAL		1075 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, FILM COATED / ORAL		1075 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, FILM COATED / ORAL		1075 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, FILM COATED / ORAL		1075 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, FILM COATED / ORAL		132 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, FILM COATED / ORAL		1075 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, FILM COATED / ORAL		132 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, FILM COATED / ORAL		1075 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FILM COATED / ORAL		2906 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FILM COATED / ORAL		2906 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, FILM COATED / ORAL		132 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, FILM COATED / ORAL		1075 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, FILM COATED / ORAL		1075 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FILM COATED / ORAL		2906 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
HYPROMELLOSES	HYPROMELLOSE	3NXW29V3WO	TABLET, FILM COATED / ORAL		582 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FILM COATED / ORAL		2906 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, FILM COATED / ORAL		132 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, FILM COATED / ORAL		1075 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	ANHYDROUS DIBASIC CALCIUM PHOSPHATE	L11K75P92J	TABLET, FILM COATED / ORAL		1075 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POLYETHYLENE GLYCOL 6000	POLYETHYLENE GLYCOL 6000	30IQX730WE	TABLET, FILM COATED / ORAL		132 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
MAGNESIUM STEARATE	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
POVIDONE	POVIDONE	FZ989GH94E	TABLET, FILM COATED / ORAL	240 mg		Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FILM COATED / ORAL		2906 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
ANHYDROUS LACTOSE	ANHYDROUS LACTOSE	3SY5LH9PMK	TABLET, FILM COATED / ORAL		2906 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, FILM COATED / ORAL		36 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, FILM COATED / ORAL		91 mg	Exact identifier — unii+route+dosage form 24 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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 · 176 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
2026-10-15 13:18:30	2026-09	A077584-001	PAROXETINE HYDROCHLORIDE	EQ 10MG BASE	TABLET / ORAL	AB	2007-03-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077584-002	PAROXETINE HYDROCHLORIDE	EQ 20MG BASE	TABLET / ORAL	AB	2007-03-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077584-003	PAROXETINE HYDROCHLORIDE	EQ 30MG BASE	TABLET / ORAL	AB	2007-03-07	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077584-004	PAROXETINE HYDROCHLORIDE	EQ 40MG BASE	TABLET / ORAL	AB	2007-03-07	`c2088c7a36db…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 176 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A077584-001	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077584-002	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077584-003	AB	1	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A077584-004	AB	1	`c2088c7a36db…`
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…`

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 HYDROCHLORIDE	Zydus Lifesciences Limited	6d5fcdb2-4d84-4b20-87e3-58a43e567500	2024-12-03		Exact identifier ndc (package): 65841-099-10 ndc (package): 65841-097-10 ndc (package): 65841-099-05 ndc (package): 65841-601-10 ndc (package): 65841-097-16 ndc (package): 65841-099-16 ndc (package): 65841-099-01 ndc (package): 65841-601-05 ndc (package): 65841-098-06 ndc (package): 65841-097-01 ndc (package): 65841-601-01 ndc (package): 65841-097-05 ndc (package): 65841-601-16 ndc (package): 65841-098-01 ndc (package): 65841-098-10 ndc (package): 65841-098-16 ndc (package): 65841-601-06 ndc (package): 65841-097-06 ndc (package): 65841-098-05 ndc (package): 65841-099-06 ndc (product): 65841-097 ndc (product): 65841-601 ndc (product): 65841-098 ndc (product): 65841-099 ndc11 (package): 65841060101 ndc11 (package): 65841009806 ndc11 (package): 65841009705 ndc11 (package): 65841009701 ndc11 (package): 65841009905 ndc11 (package): 65841060110 ndc11 (package): 65841009710 ndc11 (package): 65841009916 ndc11 (package): 65841060116 ndc11 (package): 65841009716 ndc11 (package): 65841009805 ndc11 (package): 65841009906 ndc11 (package): 65841009816 ndc11 (package): 65841060106 ndc11 (package): 65841009801 ndc11 (package): 65841009910 ndc11 (package): 65841009901 ndc11 (package): 65841009706 ndc11 (package): 65841060105 ndc11 (package): 65841009810 spl id: ef5c1ef5-2884-4395-a65a-92591c986150 spl set id: 6d5fcdb2-4d84-4b20-87e3-58a43e567500

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.