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 71 of 109 · 2,176 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ECLIPSE SPF 50 ALL SHADES	TITANIUM DIOXIDE, ZINC OXIDE	SCIENCE OF SKINCARE LLC	49df51e6-be9a-41be-b3e1-bfc062aaceaa	2025-01-09	Warnings	Exact identifier unii: 15FIX9V2JP
CoTZ Mineral Suns Stick - Tinted SPF 45	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	44a6ff9b-8067-4f32-acb2-4ede54c79e6e	2025-01-09	Warnings	Exact identifier unii: 15FIX9V2JP
TiZO Tinted Lip Protection SPF 45	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	81ee1b28-c7d7-4b34-b0f0-5a3cc7a139a2	2025-01-09	Warnings	Exact identifier unii: 15FIX9V2JP
CoTZ Face Prime and Protect SPF 40 (Tinted)	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	1088fbf6-5790-490d-b272-ec281b4b76fa	2025-01-09	Warnings	Exact identifier unii: 15FIX9V2JP
CoTZ Face Prime and Protect SPF 40 (Non-Tinted)	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	f106f52b-2157-46c7-9f7c-50f43a649050	2025-01-09	Warnings	Exact identifier unii: 15FIX9V2JP
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	ETHEREAL AESTHETICS LLC	065d17cf-bea5-137f-e063-6394a90aeeb3	2025-01-08	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	SERRAO, E JOHN MD FACOG	fea61544-6684-ad34-e053-6294a90a48f3	2025-01-08	Warnings	Exact identifier unii: 15FIX9V2JP
Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	New Beginnings Tattoo Removal	fea87de3-116f-4774-e053-6394a90a0aad	2025-01-08	Warnings	Exact identifier unii: 15FIX9V2JP
Stay AgelessTinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	PURA VIDA BODY & MIND SPA, INC.	04b38e97-c4b3-df23-e063-6394a90ae6b7	2025-01-08	Warnings	Exact identifier unii: 15FIX9V2JP
EVEN DEFENSE Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Premier Plastic Surgery	bc9221fe-89b4-4ad8-e053-2995a90aa041	2025-01-08	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Emerald Aesthetics LLC	f80f439d-f4f0-fbf3-e053-6294a90ae0ef	2025-01-08	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	Suzanne's Skin2soul LLC	fea667a1-6bec-9819-e053-6394a90a9b96	2025-01-08	Warnings	Exact identifier unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	BEAUTY SENSE MEDSPA INC	fe93a337-8d2f-35d3-e053-6294a90acb3c	2025-01-08	Warnings	Exact identifier unii: 15FIX9V2JP
Sunscreen Emulsion SPF50plus	OCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATE	Guangzhou Senmai Biotechnology Co.	1d560670-026b-bd34-e063-6394a90a9af4	2025-01-08	Warnings	Exact identifier unii: 15FIX9V2JP
Paroxetine	PAROXETINE	Zydus Pharmaceuticals USA Inc.	a6bb4f0a-1555-4550-a7a4-99609674b1e7	2025-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA077584 ndc (product): 68382-098 ndc (product): 68382-001 ndc (product): 68382-099 ndc (product): 68382-097 rxcui: 1738503 rxcui: 1738511 rxcui: 1738495 rxcui: 1738483 spl id: c88d98d1-e370-4ad8-869a-603875f276cc spl set id: a6bb4f0a-1555-4550-a7a4-99609674b1e7 unii: X2ELS050D8
sunbetter Broad Spectrum SPF 56 Sunscreen Stick Sheer	ZINC OXIDE, TITANIUM DIOXIDE	SKINBETTER SCIENCE LLC	92c4e4cb-aadc-26f4-e053-2995a90a03d5	2025-01-06	Warnings	Exact identifier unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 56 Sunscreen Compact Sheer	ZINC OXIDE, TITANIUM DIOXIDE	SKINBETTER SCIENCE LLC	b8a4986d-c28f-c4f4-e053-2a95a90a7167	2025-01-06	Warnings	Exact identifier unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 68 Sunscreen Compact Tone Smart	ZINC OXIDE, TITANIUM DIOXIDE	SKINBETTER SCIENCE LLC	8f119447-045b-43f3-e053-2995a90aea77	2025-01-06	Warnings	Exact identifier unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 75 Sunscreen Tone Smart	ZINC OXIDE, TITANIUM DIOXIDE	SKINBETTER SCIENCE LLC	b878ee3b-6897-3c4a-e053-2995a90afed7	2025-01-06	Warnings	Exact identifier unii: 15FIX9V2JP
sunbetter Broad Spectrum SPF 70 Sunscreen Sheer	ZINC OXIDE, TITANIUM DIOXIDE	SKINBETTER SCIENCE LLC	b879067b-9d7f-3a62-e053-2995a90a9d6b	2025-01-06	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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