NDC 68084-044-11 - Paroxetine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 68084-044
Requested NDC: 68084-044-11
Package NDCs from labels: 68084-044-11, 68084-044-01, 68084-044-65
Manufacturer: American Health Packaging
Effective date: 2026-05-13
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Paroxetine - American Health Packaging	American Health Packaging	2026-05-13	HUMAN PRESCRIPTION DRUG LABEL
Paroxetine - Cardinal Health	Cardinal Health	2020-06-15	HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unit	National Council for Prescription Drug Programs	2012-07-24	Indexing - Billing Unit

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 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

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

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 70 of 109 · 2,176 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CoTZ Silky Foam Non-Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	9c04b76e-ae65-4183-b475-3b8e8764db59	2025-01-24	Warnings	Exact identifier unii: 15FIX9V2JP
Paroxetine	PAROXETINE	Direct_Rx	fea936a5-fdeb-e4fb-e053-6294a90a8995	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA077584 rxcui: 1738483 unii: X2ELS050D8
Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen Backbar	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	2be9f92a-a041-0595-e063-6394a90af7a8	2025-01-17	Warnings	Exact identifier unii: 15FIX9V2JP
HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen Tinted	TITANIUM DIOXIDE, ZINC OXIDE	Hutton, Kathleen MD	293a6a6c-adf3-452d-92f5-3baceb619e39	2025-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 020	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Parfums Christian Dior	594982d5-b4bf-4889-99b7-b3cd58fa8031	2025-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Parfums Christian Dior	26f1dcde-209e-4c6d-9577-1f3d3e21595f	2025-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 000	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Parfums Christian Dior	adba288c-e94f-4b26-8f7d-336f3e5108bd	2025-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
SUNSTATION USA SPF-30 SPORT SUNSCREEN-	SUNSTATION USA SPF-30 SPORT SUNSCREEN-	Sunstation USA, LLC	2bd84b92-dcf0-404f-e063-6294a90a1060	2025-01-16		Exact identifier unii: 15FIX9V2JP
Emme Diane Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Emme Diane, Inc	ab53ad98-b667-4447-8177-724dbf771e80	2025-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Hutton, Kathleen MD	2be51fdf-c3f2-463b-8c7d-bda07db17e1b	2025-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Stay AgelessTinted Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Spectrum Aesthetics Laser Training LLC	026b9b30-ef08-bf2e-e063-6394a90a54a6	2025-01-14	Warnings	Exact identifier unii: 15FIX9V2JP
Brush and Go All Skin types	TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONE	Noon Aesthetics M.R. Ltd	9ee5b3c2-4369-4c4b-ab55-b52661b82188	2025-01-13	Warnings	Exact identifier unii: 15FIX9V2JP
Priia Tinted Mineral Sunscreen and Primer	TITANIUM DIOXIDE, ZINC OXIDE	Priia Cosmetics Inc	5c4219ac-d65f-43a5-8ec4-8732b9b344cf	2025-01-13	Warnings	Exact identifier unii: 15FIX9V2JP
Brush and Go Oily Problematic Skin	TITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONE	Noon Aesthetics M.R. Ltd	b4295453-f193-4bed-be5b-efcd91772107	2025-01-13	Warnings	Exact identifier unii: 15FIX9V2JP
Priia Tinted Mineral Sunscreen and Primer	TITANIUM DIOXIDE, ZINC OXIDE	Priia Cosmetics Inc	b2addf27-9139-48b4-85e6-618f4b5311cc	2025-01-13	Warnings	Exact identifier unii: 15FIX9V2JP
SUN PROTECT LIP BALM SPF 30	ZINC OXIDE AND TITANIUM DIOXIDE	Stream2Sea, LLC	21386652-b952-48be-b077-1acecc7f0eb0	2025-01-12	Warnings	Exact identifier unii: 15FIX9V2JP
Dermaroller Anhydrous Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Owen Biosciences, Inc.	04e82f1b-c893-4795-b7a9-0523e3ec7552	2025-01-10	Warnings	Exact identifier unii: 15FIX9V2JP
Protect Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	NEW SEASON DERMATOLOGY, PLLC	fecd72a3-c7e5-3dfa-e053-6394a90a7357	2025-01-09	Warnings	Exact identifier unii: 15FIX9V2JP
ECLIPSE SPF 50 PERFECTINT BEIGE	TITANIUM DIOXIDE, ZINC OXIDE	SCIENCE OF SKINCARE LLC	b69dda25-372f-15d9-e053-2995a90a8d3e	2025-01-09	Warnings	Exact identifier unii: 15FIX9V2JP
Extreme Protect SPF 40 All Shades	ZINC OXIDE, TITANIUM DIOXIDE	Science of Skincare, LLC.	b69db78b-5f0e-8ca2-e053-2a95a90ac88c	2025-01-09	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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