FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Paroxetine Hydrochloride - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2021-10-20HUMAN PRESCRIPTION DRUG LABEL
Paroxetine Hydrochloride - Physicians Total Care, Inc.Physicians Total Care, Inc.2011-05-17HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-2004-05EA - Each0378-20049cb25266-746c-4c3b-903c-204a346caeb312012-07-24
0378-2004-93EA - Each0378-2004d8a37f7f-5f2a-46c5-85c8-1be169fc028012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PAROXETINE HYDROCHLORIDE HEMIHYDRATEACTIVE INGREDIENTX2ELS050D8PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
TALCINACTIVE INGREDIENT7SEV7J4R1UPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
TRIACETININACTIVE INGREDIENTXHX3C3X673PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [MYLAN PHARMACEUTICALS INC.]16
PAROXETINE HYDROCHLORIDEACTIVE INGREDIENT3I3T11UD2SPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
PAROXETINEACTIVE MOIETY41VRH5220HPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
HYDROXYPROPYL CELLULOSEINACTIVE INGREDIENTRFW2ET671PPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IEPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1APAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
TRIACETININACTIVE INGREDIENTXHX3C3X673PAROXETINE HYDROCHLORIDE TABLET, FILM COATED, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]3
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMPAROXETINE 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 15 of 142 · 2,836 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Retaine Ultra PFPOLYETHYLENE GLYCOLOCuSOFT LLCa5aaaf06-772d-44d3-8601-f978ddc48ad72026-04-13WarningsExact identifier
unii: 6DC9Q167V3
unii: B697894SGQ
TRUST MD SPF30 STEM CELL FACEOCTINOXATE OCTISALATE HOMOSALATE AVOBENZONE TITANIUM DIOXIDEGuangzhou Yapheon Health Industry Co., Ltd.4f2ca12c-bc6f-61b8-e063-6294a90a0d7e2026-04-11WarningsExact identifier
unii: 15FIX9V2JP
Exovisse Preservative-Free Artificial TearsLUBRICANT EYE GEL DROPSYD BIO USA, INC.4f20191a-9124-2525-e063-6294a90a84282026-04-10WarningsExact identifier
unii: 3NXW29V3WO
Animal Hair and DanderADRENALINUM, ALLIUM CEPA, ARSENICUM IODATUM, CAT (DANDER), DOG (DANDER), EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, SABADILLA, SHEEP WOOL, SILICEANaturalCaref0067255-9310-43a0-b415-c03a0f554bcc2026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.f94a10bd-1c40-42c7-b458-b580706145492026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
Quantum ResonanceALCOHOLUS, ALUMINA SILICATA, ANACARDIUM ORIENTALE, AQUA MARINA, BAPTISIA TINCTORIA, CANDIDA ALBICANS, COLLAGEN, DNA, LAVANDULA OFFICINALIS, MEDULLA OSSIS SUIS, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NUX MOSCHATA, PHOSPHORUS, QUARTZ, SILICEA, TELA ARANEA, VALERIANA OFFICINALIS, VISCUM ALBUMDeseret Biologicals, Inc.1467111a-bef6-473d-b7f2-3309a9bb72ce2026-04-10WarningsExact identifier
unii: ETJ7Z6XBU4
uLOOK Sunscreen SPF 50SUNSCREENHAMEX GLOBAL COSMETICS LLC4e05588c-486b-60e0-e063-6294a90af4572026-04-09WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef430e8-cdc8-2897-e063-6394a90a3ac72026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE LIGHT SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4a822-a7ab-b374-e063-6394a90a85082026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE MEDIUM SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef4d44e-3421-535f-e063-6294a90a2fea2026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30 and Neutrogena Collagen Bank MoisturizerAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEAcupac Packaging, Inc.4ef5baf7-00b1-97aa-e063-6294a90aab9c2026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Mineral Ultra Sheer Face SPF 70TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef5dcd4-b2d0-bcd1-e063-6294a90a871f2026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena Mineral Invisible Daily Defense Face Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc.4ef6b5fb-5495-001c-e063-6394a90ab7b32026-04-08WarningsExact identifier
unii: 15FIX9V2JP
Nu Colour Bioadaptive BB Plus Foundation - Light GoldenTITANIUM DIOXIDENSE Products, Inc.faae6f47-19f3-41cb-8e0d-388569b5c73d2026-04-07WarningsExact identifier
unii: 15FIX9V2JP
Ultra SunscreenOCTINOXATE, OCTISALATE, TITANIUM DIOXIDEJiangsu Senwo Medical Technology Co., Ltd.4ed974b8-6c11-08e0-e063-6294a90a77132026-04-07WarningsExact identifier
unii: 15FIX9V2JP
Neutrogena MINERAL UV TINT FACE MEDIUM DEEP SPF 30TITANIUM DIOXIDE, ZINC OXIDEAcupac Packaging, Inc4ee39bbf-b7d7-8f87-e063-6294a90a25392026-04-07WarningsExact identifier
unii: 15FIX9V2JP
H-Focus FormulaAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUMHealing Natural Oils LLC4ee42911-3064-7f55-e063-6294a90abcc72026-04-07WarningsExact identifier
unii: ETJ7Z6XBU4
H-Mood FormulaAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUMHealing Natural Oils LLC4ee5c82e-9edf-c36e-e063-6394a90a237f2026-04-07WarningsExact identifier
unii: ETJ7Z6XBU4
Nu Colour Bioadaptive BB plus Foundation - BeigeTITANIUM DIOXIDENSE Products, Inc.f74e83fe-41a0-4998-ae53-30ed5af475922026-04-07WarningsExact identifier
unii: 15FIX9V2JP
LensMate Preservative-Free Artificial TearsLUBRICANT EYE DROPSYD BIO USA, INC.4ebacb2b-9b2d-6bc1-e063-6294a90a34262026-04-05WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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