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 29 of 142 · 2,836 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Intellishade Original SPF 45OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe213a681-eb22-69c0-e053-2995a90a899e2026-01-12WarningsExact identifier
unii: 15FIX9V2JP
ECHINACEAECHINACEA ANGUSTIFOLIA, HAMAMMELIS VIRGINIANA, CALCAREA PHOSPHORICA, HYDRASTIS CANADANESIS, SENEGA OFFICINALIS, SILICEA, CONIUM, AURUM MURIATICUM NATRONATUM, CALCAREA CARBONICA, FUCUS VESICULOSUS, LACHESIS MUTUSMarco Pharma International LLC.7efadb70-99e4-428b-a8ef-a2797327c6fa2026-01-12WarningsExact identifier
unii: ETJ7Z6XBU4
ODLUMIVIE Tinted Mineral SunscreenZINC OXIDE,TITANIUM DIOXIDEGuangzhou Meijiao Medical Biotechnology Co., Ltd.480d6e65-f6dc-d2a5-e063-6294a90a24a12026-01-10WarningsExact identifier
unii: 15FIX9V2JP
Vascu-Pro T009CACTUS GRANDIFLORUS, HAMAMELIS VIRGINIANA, VALERIANA OFFICINALIS, ARTERIA SUIS, HEART (SUIS), ARNICA MONTANA, AURUM METALLICUM, BARYTA MURIATICA, CHOLESTERINUM, LECITHIN, MAGNESIA MURIATICA, OXALICUM ACIDUM, PHOSPHORUSGuangzhou Renuma Medical Systems Co., Ltd01d22fd6-7d2f-4448-81ff-c88baafc0af72026-01-09WarningsExact identifier
unii: 1DI56QDM62
Sunscreen Lotion118mLZINC OXIDE 15%, TITANIUM DIOXIDE 6%, HOMOSALATE 5%, OCTISALATE 4%Foshan Sugar Max Cosmetics CO.,Ltd46355437-4068-9d03-e063-6394a90ae52c2026-01-09WarningsExact identifier
unii: 15FIX9V2JP
ST MORIZ SUNCARE FACE SUNSCREEN SPF30SUNCARE FACE SUNSCREEN SPF30Aopline Biotechnology (Guangzhou) Co., Ltd.47f26af6-4d02-3506-e063-6294a90a0fe62026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Play Mineral Broad Spectrum SPF 50TITANIUM DIOXIDE, ZINC OXIDESupergoop, LLC89088ac5-f1ee-1996-e053-2a95a90a8fdc2026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Sugargirl Set Screen SPF 30 Setting Powder Sunscreen LightZINC OXIDE, TITANIUM DIOXIDEI World LLC1fabd546-55e5-4ab2-8a1b-7b161bfbb8662026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Sugargirl Set Screen SPF 30 Setting Sunscreen MediumZINC OXIDE, TITANIUM DIOXIDEI World LLC876a6f88-8dac-4303-8acb-525999c935282026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Sugargirl Set Screen SPF 30 Setting Sunscreen TranslucentZINC OXIDE, TITANIUM DIOXIDEI World LLC0a3bae73-141b-4a47-be35-c5708dfb11802026-01-09WarningsExact identifier
unii: 15FIX9V2JP
Artistry Exact Fit Longwearing Foundation Shade Sand L2W1TITANIUM DIOXIDEAmway Corp4345cdf6-e220-4e7c-8abd-da59d2b7db842026-01-09WarningsExact identifier
unii: 15FIX9V2JP
100% Mineral Broad Spectrum Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDESupergoop LLCd6fcc065-cbcd-0b81-e053-2a95a90ab1f92026-01-09WarningsExact identifier
unii: 15FIX9V2JP
RODAN and FIELDS ENHANCEMENTS MEDIUMTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC6aa6ad3f-2c52-4031-9e6c-7526c42de71d2026-01-09WarningsExact identifier
unii: 15FIX9V2JP
RET Stomach 7001RET STOMACHProfessional Complementary Health Formulas086427e0-599e-4405-a996-d949023f9d902026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Organophosphate Combination 9309ORGANOPHOSPHATE COMBINATIONProfessional Complementary Health Formulasf777015f-1df6-4821-af63-543175313aba2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Lawn and Garden Detox 6026LAWN AND GARDEN DETOXProfessional Complementary Health Formulas2db4bdd8-1049-450a-8642-0e1dbbe5abb32026-01-08WarningsExact identifier
unii: 15FIX9V2JP
Low Vaccinosis Nosode 4024LOW VACCINOSIS NOSODEProfessional Complementary Health Formulasf347ac8f-ac05-46ef-91a3-9f7e000347682026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
First Chakra (Root) 7301FIRST CHAKRA (ROOT)Professional Complementary Health Formulas61eb1bbe-6675-4369-b852-18975e6b08c72026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Second Chakra (Sacral) 7302SECOND CHAKRA (SACRAL)Professional Complementary Health Formulasea8a69d3-66fc-4b21-bfdd-c207dd2935892026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Silicea 8012SILICEAProfessional Complementary Health Formulasa2a1eae8-24c8-44dd-9b9d-1826fa7164332026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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