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 84 of 109 · 2,172 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
H.E.B. Mineral Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	H.E.B.	c5279caf-3af9-d163-e053-2995a90a943b	2024-10-15	Warnings	Exact identifier unii: 15FIX9V2JP
Target Up and Up Mineral Sunscreen Broad Spectrum SPF 50 Reef-Conscious Formula	TITANIUM DIOXIDE, ZINC OXIDE	TARGET CORPORATION	cfd735d2-df3a-5ed0-e053-2995a90a9f26	2024-10-14	Warnings	Exact identifier unii: 15FIX9V2JP
Target Up and Up SPF 50 Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	TARGET CORPORATION	f99028fa-a17e-4a84-e053-6294a90a927f	2024-10-14	Warnings	Exact identifier unii: 15FIX9V2JP
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.102	ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE	AMOREPACIFIC CORPORATION	531f60c9-c89a-46bc-8460-d01b2e838e6f	2024-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
AMOREPACIFIC COLOR CONTROL CUSHION COMPACT NO.104	OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDE	AMOREPACIFIC CORPORATION	60964d9f-d96c-4397-b273-6b63d1886722	2024-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
IOPE AIR CUSHION Cover 21 Vanilla	ZINC OXIDE, OCTINOXATE, AND TITANIUM DIOXIDE	AMOREPACIFIC CORPORATION	29d6cc8d-1469-479d-a15a-e78d4e22d4a2	2024-10-08	Warnings	Exact identifier unii: 15FIX9V2JP
DermacinRx Skin Moisturizing Ultra SPF 50 Sunscreen	AVOBENZONE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE	PureTek Corporation	86eb06cc-d63f-4500-a52e-14ef99a56532	2024-10-02	Warnings	Exact identifier unii: 15FIX9V2JP
TiZO2	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	43bec652-3f2c-4671-8a0c-c4c4a4bfcc7a	2024-10-01	Warnings	Exact identifier unii: 15FIX9V2JP
Advanced Eye Relief/ Redness Maximum Relief	NAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSE	Bausch & Lomb Incorporated	3c11285a-7e86-4b47-b1ee-e7d59858087d	2024-09-25	Warnings	Exact identifier unii: 3NXW29V3WO
Paroxetine	PAROXETINE	ANI Pharmaceuticals, Inc.	134e76f0-45cf-47eb-b6e1-cdb3bb522a0a	2024-09-16	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: X2ELS050D8
Proceuticals Private Label by TiZO tinted mineral sunscreen stick	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, Ltd	2179a2ff-9425-5b2c-e063-6294a90a45b6	2024-09-06	Warnings	Exact identifier unii: 15FIX9V2JP
paroxetine hydrochloride	PAROXETINE HYDROCHLORIDE	Bryant Ranch Prepack	c3c204df-6b7d-42fb-8794-4f38064ed963	2024-09-06	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1738503 unii: X2ELS050D8
EltaMD UV Physical Rosy Tint SPF40	TITANIUM DIOXIDE, ZINC OXIDE SUNSCREEN	CP Skin Health Group, Inc	6bc4d2d4-ef62-4ec0-b514-17257603bac2	2024-09-05	Warnings	Exact identifier unii: 15FIX9V2JP
Proceuticals Private Label by TiZO non-tinted mineral sunscreen stick	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, Ltd	20e86260-d641-c9ac-e063-6394a90ac07d	2024-08-30	Warnings	Exact identifier unii: 15FIX9V2JP
Freaks of Nature Peak Performance SPF50	FREAKS OF NATURE PEAK PERFORMANCE SPF50	Milbar Laboratories	20b18cea-95e9-3527-e063-6294a90a4db4	2024-08-30	Warnings	Exact identifier unii: 15FIX9V2JP
Paroxetine	PAROXETINE	Bryant Ranch Prepack	40dcf270-64bb-bca0-db08-6b233a3430f8	2024-08-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA077584 rxcui: 1738495 unii: X2ELS050D8
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30	TITANIUM DIOXIDE AND ZINC OXIDE	Dermio Dermatology LLC	204973ce-dba4-8235-e063-6394a90a015c	2024-08-22	Warnings	Exact identifier unii: 15FIX9V2JP
MACKENZIES OCEAN SAFE SUNSCREEN	TITANIUM DIOXIDE	Naturally Uncommon, LLC	1fd0a790-c66c-216f-e063-6294a90ae971	2024-08-16	Warnings	Exact identifier unii: 15FIX9V2JP
Proceuticals Private Label by TiZO non-tinted foaming mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, Ltd	1f4491ab-95b0-cc14-e063-6394a90a73ca	2024-08-09	Warnings	Exact identifier unii: 15FIX9V2JP
paroxetine hydrochloride	PAROXETINE HYDROCHLORIDE	Oxford Pharmaceuticals, LLC	25182b68-8f7a-48e8-9788-6818b0984b29	2024-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1738503 rxcui: 1738511 rxcui: 1738495 rxcui: 1738483 unii: X2ELS050D8

Reported adverse events (FAERS/openFDA)#

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