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 86 of 109 · 2,172 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Fair Light	TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	6377c0f7-e2cb-44f0-9786-42c5a9d02f88	2024-08-04	Warnings	Exact identifier unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Light	TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	e98696d2-7f7f-4a4c-b8ae-849f2d211a04	2024-08-04	Warnings	Exact identifier unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	f31842f7-3474-4462-87e2-c4ebde97a583	2024-08-04	Warnings	Exact identifier unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Longwear Cushion Medium	TITANIUM DIOXIDE, OCTINOXATE, ZINC OXIDE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	ccfafefc-fff4-41ff-baf4-3f430c690be7	2024-08-04	Warnings	Exact identifier unii: 15FIX9V2JP
Essential Sheer SPF 50	ZINC OXIDE TITANIUM DIOXIDE	Topiderm, Inc.	2132dc18-85ee-4449-86d2-d9f698f286c6	2024-07-31	Warnings	Exact identifier unii: 15FIX9V2JP
Proceuticals Private Label by TiZO tinted foaming mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, Ltd	1e78109f-4d2e-2705-e063-6294a90a5ad3	2024-07-30	Warnings	Exact identifier unii: 15FIX9V2JP
Replenix Sheer SPF 50	ZINC OXIDE TITANIUM DIOXIDE	Topiderm, Inc.	37d1f454-3bc9-4ce5-863c-0d4f6fa18fb4	2024-07-29	Warnings	Exact identifier unii: 15FIX9V2JP
Derma E Sun Defense Face SPF 30	ZINC OXIDE TITANIUM DIOXIDE	derma e	d90b8f81-de7a-4022-800a-90f063e94180	2024-07-17	Warnings	Exact identifier unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO mineral lip sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	1d611494-648b-6e5f-e063-6294a90a4500	2024-07-16	Warnings	Exact identifier unii: 15FIX9V2JP
SkinCeuticals Physical Fusion UV Defense Broad Spectrum SPF 50 Sunscreen	TITANIUM DIOXIDE AND ZINC OXIDE	L'Oreal USA Products Inc	8df98d97-a5d2-4d52-8bd2-130a13501d60	2024-07-16	Warnings	Exact identifier unii: 15FIX9V2JP
Paroxetine	PAROXETINE	NuCare Pharmaceuticals,Inc.	570a9f0d-04fb-2922-e054-00144ff88e88	2024-07-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA077584 rxcui: 1738483 unii: X2ELS050D8
Derma E Sun Defense SPF 30	ZINC OXIDE AND TITANIUM DIOXIDE	derma e	395b73a4-dae7-49da-9dab-ab622117c8c0	2024-07-12	Warnings	Exact identifier unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO non-tinted mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	1ce8c1da-565d-5487-e063-6294a90a1bde	2024-07-10	Warnings	Exact identifier unii: 15FIX9V2JP
PROCEUTICALS PRIVATE LABEL by TiZO daily defense tinted mineral sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	1cc19337-cf54-af5d-e063-6394a90a1ceb	2024-07-08	Warnings	Exact identifier unii: 15FIX9V2JP
Exel Clarifying Line SPF 50	OCTINOXATE, OCTOCRYLENE, OXYBENZONE, TATANIUM DIOXIDE	Exelencia importers	0d6d4098-4121-477e-b404-3ab18628ed68	2024-06-30	Warnings	Exact identifier unii: 15FIX9V2JP
Maybelline New York Dream Fresh BB Beauty Balm Skin Perfector Broad Spectrum SPF 30 Sunscreen	TITANIUM DIOXIDE	L'Oreal USA Products Inc	28c51c59-dbfb-45e5-b536-6e5d5c5560d6	2024-06-28	Warnings	Exact identifier unii: 15FIX9V2JP
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Bryant Ranch Prepack	ac6ea24f-a9f3-4413-8c3a-9e2e4ca93c0f	2024-06-28	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1738511 unii: X2ELS050D8
LOreal Paris Infallible UP TO 32H Fresh Wear Foundation Broad Spectrum SPF 25 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	f6457973-3718-44cd-a764-de0b089d4eee	2024-06-28	Warnings	Exact identifier unii: 15FIX9V2JP
LOreal Paris Visible Lift Serum Absolute Advanced Makeup Broad Spectrum SPF 17 Sunscreen	OCTINOXATE AND TITANIUM DIOXIDE	L'Oreal USA Products Inc	8598d56b-adcd-48e8-b6fc-77bc934009c7	2024-06-27	Warnings	Exact identifier unii: 15FIX9V2JP
Paroxetine	PAROXETINE HYDROCHLORIDE HEMIHYDRATE	Proficient Rx LP	ce168c41-a860-45f5-bae8-7b3d9b48d86a	2024-06-27	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1738483 unii: X2ELS050D8

Reported adverse events (FAERS/openFDA)#

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