NDC 0378-2004-05 - Paroxetine Hydrochloride

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: 0378-2004
Requested NDC: 0378-2004-05
Package NDCs from labels: 0378-2004-93, 0378-2004-05
Manufacturer: Mylan Pharmaceuticals Inc.
Effective date: 2021-10-20
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Paroxetine Hydrochloride - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2021-10-20	HUMAN PRESCRIPTION DRUG LABEL
Paroxetine Hydrochloride - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2011-05-17	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-2004-05	EA - Each	0378-2004	9cb25266-746c-4c3b-903c-204a346caeb3	1	2012-07-24
0378-2004-93	EA - Each	0378-2004	d8a37f7f-5f2a-46c5-85c8-1be169fc0280	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 HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
SODIUM ALGINATE	INACTIVE INGREDIENT	C269C4G2ZQ	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]	16
PAROXETINE HYDROCHLORIDE	ACTIVE INGREDIENT	3I3T11UD2S	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
PAROXETINE	ACTIVE MOIETY	41VRH5220H	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
D&C RED NO. 30	INACTIVE INGREDIENT	2S42T2808B	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
POLYDEXTROSE	INACTIVE INGREDIENT	VH2XOU12IE	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
TRIACETIN	INACTIVE INGREDIENT	XHX3C3X673	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3

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 13 of 142 · 2,836 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anything SPF	OCTINOXATE, OCTISALATE, ZINC OXIDE, AVOBENZONE, HOMOSALATE, TITANIUM DIOXIDE	Anything SPF LLC	508b8dcb-6600-6dad-e063-6294a90a565a	2026-04-28	Warnings	Exact identifier unii: 15FIX9V2JP
Johnsons Baby Mineral Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Kenvue Brands LLC	4fe04c4b-2751-0561-e063-6394a90af768	2026-04-22	Warnings	Exact identifier unii: 15FIX9V2JP
Lazy Face SPF 30 Facescreen	TITANIUM DIOXIDE, ZINC OXIDE	Sunny Day Creations	500ee303-7302-68d5-e063-6394a90ac6d4	2026-04-22	Warnings	Exact identifier unii: 15FIX9V2JP
ELROEL Pang Pang Sun Cushion S7	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	MONOGLOT HOLDINGS Inc.	256bf56f-aefa-47ce-890c-5a3896c11b92	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	3a43c7c0-7468-4b7a-95b9-f03e37f1b49b	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	a251eb20-02e6-4b55-b969-c1bef2f9d732	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Fair Pink	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	6684d69a-89ff-41e8-81f0-3e2367811a18	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	bf24d081-85f7-4a26-9416-ecff1fe59dec	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Pink Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	4a09a01a-404f-4b67-91e0-666153f550e8	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion N-Light	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	cf7c4445-0382-47ab-aba9-b40d63e4f1cc	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Medium	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	80c60ffa-69e0-4b31-bd0d-fc8ff9936ba0	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Medium Deep	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	0e18d601-700a-4c1c-a434-22582253bd95	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
JUNGSAEMMOOL Essential Skin Nuder Cushion Bronze	TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	Jungsaemmool Beauty Co., Ltd.	ddb3aa5e-cd1a-4792-b1b1-3604b368e010	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-DEEP	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	0e246e64-2eab-1219-e063-6294a90a79a8	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-FAIR GLOW	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	316cd8a3-3d62-83ac-e063-6394a90a4afa	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- HONEY GLOW	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	0e2424f4-0011-42b0-e063-6394a90a780d	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-LIGHT	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	316cfaea-b71f-2956-e063-6294a90a4f20	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20-MEDIUM	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	316d1515-6092-a7d6-e063-6394a90ab8b2	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20- MEDIUM DEEP	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	0e246e70-6ec3-5711-e063-6394a90a3879	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR NAME MINERAL SHEERTINT BROAD SPECTRUM SPF 20	YOUR NAME MINERAL SHEER TINT	PML NYC, LLC	0e241343-db63-3f1c-e063-6394a90ab538	2026-04-17	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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