FDA.reportPublic FDA data

NDC 0904-6248 - VENLAFAXINE 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
0904-6248
Package NDCs from labels
0904-6248-61
Manufacturer
Major Pharmaceuticals
Effective date
2018-08-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
VENLAFAXINE HYDROCHLORIDE - Major PharmaceuticalsMajor Pharmaceuticals2018-08-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6248-61EA - Each0904-624806a1dd4d-f9e4-4c53-9030-c3af3deff6eb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]8
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]8
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]8
ETHYLCELLULOSESINACTIVE INGREDIENT7Z8S9VYZ4BVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]8
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]8
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]8
GELATININACTIVE INGREDIENT2G86QN327LVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]8
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]8
POVIDONE K30INACTIVE INGREDIENTU725QWY32XVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4VENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]8
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]8
TALCINACTIVE INGREDIENT7SEV7J4R1UVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]8
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMVENLAFAXINE HYDROCHLORIDE CAPSULE, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]8

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 91 of 147 · 2,932 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-117ATROPA BELLADONNA AND SILICON DIOXIDEDNA Labs, Inc.8bcce284-f8f3-4d62-a13e-b93c2c655a702025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-109ATROPA BELLADONNA, VIROLA SEBIFERA RESIN, SILICON DIOXIDE, CALCIUM FLUORIDE, SODIUM BORATE, GOLD, BAPTISIA TINCTORIA ROOT, MERCURIC CYANIDE, CALOMEL, AND CORNUS RUGOSA WHOLEDNA Labs, Inc.7758341d-e0be-487a-ba47-8847551231e12025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-137APIS MELLIFERA, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA, ATROPA BELLADONNA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, CALCIUM SULFIDE, RANCID BEEF, SULFUR, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGDNA Labs, Inc.240d03c0-957b-48e4-9bab-43f9e6b8fb422025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-133CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATEDNA Labs, Inc.a250b7e9-7fd2-4cb0-82f3-baa089d174412025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
Brush and Go All Skin typesTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltd9ee5b3c2-4369-4c4b-ab55-b52661b821882025-01-13WarningsExact identifier
unii: 15FIX9V2JP
Priia Tinted Mineral Sunscreen and PrimerTITANIUM DIOXIDE, ZINC OXIDEPriia Cosmetics Inc5c4219ac-d65f-43a5-8ec4-8732b9b344cf2025-01-13WarningsExact identifier
unii: 15FIX9V2JP
Brush and Go Oily Problematic SkinTITANIUM DIOXIDE, OCTINOXATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE, AND OXYBENZONENoon Aesthetics M.R. Ltdb4295453-f193-4bed-be5b-efcd917721072025-01-13WarningsExact identifier
unii: 15FIX9V2JP
Priia Tinted Mineral Sunscreen and PrimerTITANIUM DIOXIDE, ZINC OXIDEPriia Cosmetics Incb2addf27-9139-48b4-85e6-618f4b5311cc2025-01-13WarningsExact identifier
unii: 15FIX9V2JP
SUN PROTECT LIP BALM SPF 30ZINC OXIDE AND TITANIUM DIOXIDEStream2Sea, LLC21386652-b952-48be-b077-1acecc7f0eb02025-01-12WarningsExact identifier
unii: 15FIX9V2JP
VENLAFAXINE HYDROCHLORIDEVENLAFAXINEBluePoint Laboratories5efe1336-c796-4560-8110-a64c80eefb0c2025-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Dermaroller Anhydrous Sunscreen SPF 30TITANIUM DIOXIDE, ZINC OXIDEOwen Biosciences, Inc.04e82f1b-c893-4795-b7a9-0523e3ec75522025-01-10WarningsExact identifier
unii: 15FIX9V2JP
Aurum HypericumAURUM HYPERICUMUriel Pharmacy Incbe0da1f0-06a1-11df-8a39-0800200c9a662025-01-10WarningsExact identifier
unii: ETJ7Z6XBU4
Premixed saline packetsSODIUM CHLORIDE, SODIUM BICARBONATEShenzhen Kerui lntl Trading Co., Ltd0d11e07b-c137-6efc-e063-6394a90a6bba2025-01-09WarningsExact identifier
unii: 8MDF5V39QO
Protect Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDENEW SEASON DERMATOLOGY, PLLCfecd72a3-c7e5-3dfa-e053-6394a90a73572025-01-09WarningsExact identifier
unii: 15FIX9V2JP
ECLIPSE SPF 50 PERFECTINT BEIGETITANIUM DIOXIDE, ZINC OXIDESCIENCE OF SKINCARE LLCb69dda25-372f-15d9-e053-2995a90a8d3e2025-01-09WarningsExact identifier
unii: 15FIX9V2JP
Extreme Protect SPF 40 All ShadesZINC OXIDE, TITANIUM DIOXIDEScience of Skincare, LLC.b69db78b-5f0e-8ca2-e053-2a95a90ac88c2025-01-09WarningsExact identifier
unii: 15FIX9V2JP
ECLIPSE SPF 50 ALL SHADESTITANIUM DIOXIDE, ZINC OXIDESCIENCE OF SKINCARE LLC49df51e6-be9a-41be-b3e1-bfc062aaceaa2025-01-09WarningsExact identifier
unii: 15FIX9V2JP
AM-9SPIGELIA ANTHELMIA, SILICON DIOXIDE, AND CORALLIUM RUBRUM WHOLEDNA Labs, Inc.d7a00f0b-de4c-4bff-b8e0-86a82bed8bb92025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-8SILICON DIOXIDE, ATROPA BELLADONNA, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, PALLADIUM, APIS MELLIFERA, AND BOS TAURUS OVARYDNA Labs, Inc.c25cdcb5-9469-48bb-b216-0a9d8d644e122025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-23ANEMONE PULSATILLA, PHOSPHORUS, SILICON DIOXIDE, NITRIC ACID, ARSENIC TRIOXIDE, TOXICODENDRON PUBESCENS WHOLE, AND BOS TAURUS HYPOTHALAMUSDNA Labs, Inc.b6365b49-06fb-4692-96f7-a5097b70bc912025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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