FDA.reportPublic FDA data

NDC 70710-1348-01 - Venlafaxine

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
70710-1348
Requested NDC
70710-1348-01
Package NDCs from labels
70710-1348-1, 70710-1348-3, 70710-1348-9, 70710-1348-01
Manufacturer
Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited
Effective date
2023-09-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Venlafaxine - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2023-09-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1348-1Venlafaxine100 in 1 BOTTLETABLET, EXTENDED RELEASE1002
70710-1348-3Venlafaxine30 in 1 BOTTLETABLET, EXTENDED RELEASE302
70710-1348-9Venlafaxine90 in 1 BOTTLETABLET, EXTENDED RELEASE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1348VENLAFAXINE TABLET, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]2Current NDC, Legacy NDC, 3 package rows20230903_db1d16b3-d1a2-4f41-adff-a87c17689aa0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1348-3EA - Each70710-1348c51943ba-6be5-418f-ad8f-15ea66dd18b912022-12-07
70710-1348-9EA - Each70710-13482c284087-b944-43e8-8cb2-84709fca8dfb12022-12-07

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 41 of 48 · 957 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
unii: 6DC9Q167V3
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 6DC9Q167V3
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
unii: 6DC9Q167V3
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
unii: 6DC9Q167V3
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
unii: 6DC9Q167V3
VenlafaxineVENLAFAXINEZydus Pharmaceuticals USA Inc.db1d16b3-d1a2-4f41-adff-a87c17689aa02023-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA215622
ndc (package): 70710-1349-3
ndc (package): 70710-1350-1
ndc (package): 70710-1352-9
ndc (package): 70710-1349-1
ndc (package): 70710-1350-9
ndc (package): 70710-1350-3
ndc (package): 70710-1349-9
ndc (package): 70710-1348-3
ndc (package): 70710-1348-9
ndc (package): 70710-1352-3
ndc (package): 70710-1352-1
ndc (package): 70710-1348-1
ndc (product): 70710-1348
ndc (product): 70710-1350
ndc (product): 70710-1352
ndc (product): 70710-1349
ndc11 (package): 70710134801
rxcui: 808753
rxcui: 808751
rxcui: 808748
rxcui: 808744
spl id: 479c565e-3c2f-42a1-8a19-b7a210e5f28d
spl set id: db1d16b3-d1a2-4f41-adff-a87c17689aa0
unii: 7D7RX5A8MO
Hydrate IICOFFEA TOSTA, AVENA SATIVA, EQUISETUM HYEMALE, HYPERICUM PERFORMATUM, GINKGO BILOBA, GERMANIUM SESQUIOXIDE, SILICEABioActive Nutritional, Inc.2d3657d9-d4f4-426c-b381-dbfde9b8e2cd2023-09-01WarningsExact identifier
unii: ETJ7Z6XBU4
VenlafaxineVENLAFAXINEBluePoint Laboratories172b3d3d-bdae-47bf-8fba-edd6da1a86492023-08-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
VenlafaxineVENLAFAXINEZydus Pharmaceuticals USA Inc.72efad5f-0909-46a5-aa13-ac24fe015fe62023-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Venlafaxine HydrochlorideVENLAFAXINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.37aaa8ac-4e0c-4e04-98b5-19b0d90d857c2023-08-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
venlafaxineVENLAFAXINEAlembic Pharmaceuticals Inc.67b323a7-a8c9-410f-bff0-0e515bef41a72023-08-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
BABY MUCUS PLUS COLD RELIEFBRYONIA ALBA ROOT, EUPHRASIA STRICTA, CALCIUM SULFIDE, SODIUM CHLORIDE, PHOSPHORUS, ANEMONE PULSATILLA, RUMEX CRISPUS ROOT, AND SILICON DIOXIDEHyland's Inc.d934cc8a-1e43-4942-858a-05b5d068679a2023-08-22WarningsExact identifier
unii: ETJ7Z6XBU4
B HPAPIS MELLIFICA, ARSENICUM ALBUM, BELLADONNA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), LACHESIS MUTUS, MERCURIUS SOLUBILIS, PULSATILLA (VULGARIS), PYROGENIUM, RHUS TOX, SILICEAEnergique, Inc.8b1414d5-57d8-46d5-b4be-3011429bdd0d2023-08-21WarningsExact identifier
unii: ETJ7Z6XBU4
VenlafaxineVENLAFAXINE HYDROCHLORIDEAurobindo Pharma Limitedb23637e5-d37f-41b5-ba76-fc053e903bc22023-08-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
PituistatARALIA QUINQUEFOLIA, GINKGO BILOBA, ARSENICUM IODATUM, AVENA SATIVA, BARYTA CARBONICA, PHOSPHORUS, SILICEA, THYROIDINUM (SUIS), ALUMINUM, ANTIMONY, BARIUM, BERYLLIUM, BISMUTH, BORON, BROMINE, CALCIUM, CARBON, CERIUM, CESIUM, CHLORIDE, CHROMIUM, COBALT, COPPER, DYSPROSIUM, ERBIUM, EUROPIUM, FLUORIDE, GADOLINIUM, GALLIUM, GERMANIUM, GOLD, HAFNIUM, HOLMIUM, INDIUM, IODINE, IRIDIUM, IRON, LANTHANUM, LITHIUM, LUTETIUM, MAGNESIUM, MANGANESE, MOLYBDENUM, NEODYMIUM, NICKEL, NIOBIUM, OSMIUM, PALLADIUMEnergique, Inc.27a5fccb-8707-4bb5-a848-d1921bba2f7f2023-08-21WarningsExact identifier
unii: ETJ7Z6XBU4
venlafaxineVENLAFAXINE HYDROCHLORIDERising Pharma Holdings, Inc.20319949-ccf9-477a-a6e3-53502772deb92023-08-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
Effexor XRVENLAFAXINE HYDROCHLORIDEViatris Specialty LLCc848a5d8-ba94-4c84-80e3-0bf35fb8e32e2023-08-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO
MannitolMANNITOLB. Braun Medical Inc.d12cc802-b538-4065-a264-f474ff3b30432023-08-15Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
CellergyCALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, FERRUM PHOSPHORICUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SILICEA.Ratis, LLC2aebc11e-eeb7-436b-b90c-3a2f59fb74922023-08-07WarningsExact identifier
unii: ETJ7Z6XBU4
VENLAFAXINEVENLAFAXINECadila Pharmaceuticals Limited2ed61dcf-42e3-47cf-a607-459eef5fea982023-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 7D7RX5A8MO

Reported adverse events (FAERS/openFDA)#

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