FDA.reportPublic FDA data

NDC 51079-482-01 - 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
51079-482
Requested NDC
51079-482-01
Package NDCs from labels
51079-482-01, 51079-482-20, 51079-482-30, 51079-482-56
Manufacturer
Mylan Institutional Inc.
Effective date
2019-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Venlafaxine Hydrochloride - Mylan Institutional Inc.Mylan Institutional Inc.2019-12-30HUMAN 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
51079-482-01EA - Each51079-482181fe983-1e2f-4d20-84bf-51e53db1212612012-07-24
51079-482-20EA - Each51079-482cbf3fe5a-d048-46ad-89b7-5a5cfa7f508312012-07-24
51079-482-30EA - Each51079-4821a7dbecb-81f9-4650-b988-139fbc953ff512012-07-24
51079-482-56EA - Each51079-482dee24509-5ac9-412e-88fb-42db5c2f401512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VENLAFAXINE HYDROCHLORIDEACTIVE INGREDIENT7D7RX5A8MOVENLAFAXINE TABLET [MYLAN INSTITUTIONAL INC.]4
VENLAFAXINEACTIVE MOIETYGRZ5RCB1QGVENLAFAXINE TABLET [MYLAN INSTITUTIONAL INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UVENLAFAXINE TABLET [MYLAN INSTITUTIONAL INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GVENLAFAXINE TABLET [MYLAN INSTITUTIONAL INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XVENLAFAXINE TABLET [MYLAN INSTITUTIONAL INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30VENLAFAXINE TABLET [MYLAN INSTITUTIONAL INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EVENLAFAXINE TABLET [MYLAN INSTITUTIONAL INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JVENLAFAXINE TABLET [MYLAN INSTITUTIONAL INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2VENLAFAXINE TABLET [MYLAN INSTITUTIONAL INC.]4

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 1 of 13 · 252 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
venlafaxine hydrochloride, extended releaseVENLAFAXINE HYDROCHLORIDE, EXTENDED RELEASEEdenbridge Pharmaceuticals LLC.38431a76-6185-4c17-994f-8278b6cd75102026-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.c41d847b-88ba-49a5-9d73-269ac4caa4ed2026-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.963e5599-f9af-45c2-8cf4-13cf52eed6a02026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINEREMEDYREPACK INC.e14bfb9f-3bd2-4419-9294-9c286e79730a2026-08-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINEREMEDYREPACK INC.9df3a51c-1b89-4d2a-8f41-3755910e9bfb2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.33b39416-7981-46fb-ba31-e933a6afcf8b2026-08-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
VENLAFAXINE HYDROCHLORIDEVENLAFAXINE HYDROCHLORIDEAdvagen Pharma Ltd.48a75840-64e4-4d44-9a62-0093730031052026-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
VenlafaxineVENLAFAXINEREMEDYREPACK INC.1ce5786e-22e6-4afa-8052-6eababc6aa4e2026-08-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDENCS HealthCare of KY, LLC dba Vangard Labs3eef522f-9e95-4668-bb12-09fd47ed0daf2026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEPURACAP LABORATORIES LLC DBA BLU PHARMACEUTICALSb1d21366-f686-4e20-a10f-0c25f517db382026-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.f56a0f70-bbb1-4e69-b969-965a72f0e2f02026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.4e3053b9-cdec-4f4d-85ae-2e55cf1cc1852026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.50d3b487-9f65-4e2f-b6eb-9533964f89722026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDEREMEDYREPACK INC.ac9b972d-8b8a-4727-90c2-b208f91272fd2026-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO

Reported adverse events (FAERS/openFDA)#

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