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 39 of 142 · 2,836 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Quality Choice Lubricant Eye Drops Long Lasting	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Chain Drug Marketing Assoc., Inc.	0cd91c45-88a2-f88c-e063-6294a90ad127	2025-12-30	Warnings	Exact identifier unii: 6DC9Q167V3 unii: B697894SGQ
Archies Dry Eye Relief	POLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL	Archie's Remedies	07da099b-6b7f-984d-e063-6294a90a12ac	2025-12-30	Warnings	Exact identifier unii: 6DC9Q167V3 unii: B697894SGQ
Equaline Multi-Symptom Eye Drops	POLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATE	United Natural Foods, Inc.	fe467606-6d66-b695-e053-6294a90aab5d	2025-12-30	Warnings	Exact identifier unii: B697894SGQ
SPF 30 Sunscreen	ZINC OXIDE, TITANIUM DIOXIDE	CLEURE	f5512f34-08ee-b0f6-e053-2a95a90ab5bd	2025-12-29	Warnings	Exact identifier unii: 15FIX9V2JP
RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20	OCTINOXATE AND TITANIUM DIOXIDE	ESTEE LAUDER INC	897b8edb-f089-4a49-baca-e05806b0a068	2025-12-29	Warnings	Exact identifier unii: 15FIX9V2JP
OI LIN SUNMILK SUNSCREEN SPF 30	SUNSCREEN, TITANIUM DIOXIDE	Sunrider Manufacturing L.P.	26b57314-1616-4ca4-b65f-a363c525b432	2025-12-29	Warnings	Exact identifier unii: 15FIX9V2JP
StellaLife VEGA Oral Care	SPRAY	StellaLife, Inc.	b8ba495e-2cfe-092c-e053-2995a90a3fd3	2025-12-24	Warnings	Exact identifier unii: ETJ7Z6XBU4
StellaLife VEGA Oral Care Recovery Kit	KIT	Homeocare Laboratories, Inc.	b701234a-0bd2-16d3-e053-2995a90a5b13	2025-12-24	Warnings	Exact identifier unii: ETJ7Z6XBU4
TINTED FACIAL SUNSCREEN	ZINC OXIDE, TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	1259035e-9196-97de-e063-6394a90a9dec	2025-12-22	Warnings	Exact identifier unii: 15FIX9V2JP
SPF 50 MINERAL SUNSCREEN LIP	ZINC OXIDE , TITANIUM DIOXIDE	Guangzhou Tata Biotechnology Co., Ltd.	1c6f0964-9bee-1c06-e063-6294a90ac2a4	2025-12-22	Warnings	Exact identifier unii: 15FIX9V2JP
PAROXETINE	PAROXETINE	Chartwell RX, LLC.	69699d40-4a64-4337-8664-e4e093437fbf	2025-12-22	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: X2ELS050D8
G.M. Collin FPS-SPF 50 UVA-UVB TINTED SUNSCREEN	ZINC OXIDE, TITANIUM DIOXIDE	LABORATOIRES DERMO-COSMETIK INC.	468c90d7-3b9e-1641-e063-6394a90a928c	2025-12-22	Warnings	Exact identifier unii: 15FIX9V2JP
TiZO3	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	468d6476-127a-e9f0-e063-6294a90a3df9	2025-12-22	Warnings	Exact identifier unii: 15FIX9V2JP
YOUR SKIN BUT BETTER FAIR	TITANIUM DIOXIDE AND ZINC OXIDE	IT COSMETICS, LLC	3e65ec1a-0ed9-433d-8da9-a6cb61829911	2025-12-22	Warnings	Exact identifier unii: 15FIX9V2JP
StellaLife VEGA Oral Care Peppermint Pain and Swelling Relief	ARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, LEDUM PALUSTRE, RUTA, SILICEA, STAPHYSAGRIA	StellaLife, Inc.	10d42c12-713a-f461-e063-6294a90a223b	2025-12-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
StellaLife VEGA Oral Care Pain and Swelling Relief	ARNICA, CALENDULA, CHAMOMILLA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, HEPAR SULPH CALC, HYPERICUM, LGNATIA, RUTA, STAPHYSAGRIA	StellaLife, Inc.	10f8dee1-d5d3-0602-e063-6294a90a6dbf	2025-12-22	Warnings	Exact identifier unii: ETJ7Z6XBU4
THE MELT MIST Sheerest Mineral Mist Suncare for Body	TITANIUM DIOXIDE, ZINC OXIDE	Dune Suncare, Inc.	465d3277-7798-512a-e063-6294a90a2065	2025-12-20	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 9N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	7287078e-67ff-41fe-bc8d-59b2146f5dc9	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2WO	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b6095639-e2ee-418e-b4f1-e59da1bd9216	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 2N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	8c6466a6-4f11-4210-bb02-eb31c15984cd	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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