FDA.reportPublic FDA data

NDC 0480-3313-14 - Tolvaptan

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
0480-3313
Requested NDC
0480-3313-14
Package NDCs from labels
0480-3313-14, 0480-3313-66
Manufacturer
Teva Pharmaceuticals, Inc.
Effective date
2025-03-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tolvaptan - Teva Pharmaceuticals, Inc.Teva Pharmaceuticals, Inc.2025-03-09HUMAN PRESCRIPTION DRUG LABEL

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 1 ยท 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TolvaptanTOLVAPTANAscend Laboratories, LLC82ef58ef-ce46-434e-bf99-89fce51094f12026-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2719337
rxcui: 2044966
rxcui: 2274815
rxcui: 2719335
rxcui: 2044359
rxcui: 2274813
rxcui: 2044367
rxcui: 2044968
rxcui: 2044970
rxcui: 2044363
unii: 21G72T1950
TolvaptanTOLVAPTANPar Health USA, LLC5b14ba2b-9f80-41d6-9613-f16d3cf37d252026-08-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 21G72T1950
SAMSCATOLVAPTANOtsuka America Pharmaceutical, Inc.5526617c-c7b9-4556-886d-729bbabbc5662026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 21G72T1950
TOLVAPTANTOLVAPTANNorthstar Rx LLCc075d517-f4c8-469a-9f51-416ef61c6a832026-04-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 21G72T1950
TRIMO SANOXYQUINOLINE SULFATE AND SODIUM LAURYL SULFATECooperSurgical, Inc.1e4a1caa-e6ba-44ef-8347-07e6385a7c9e2025-09-03WarningsExact identifier
unii: 368GB5141J
TOLVAPTANTOLVAPTANLupin Pharmaceuticals, Inc.9ba38e23-ca66-4406-92af-bbb8fad00e162025-05-09Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2719337
rxcui: 2044966
rxcui: 2274815
rxcui: 2719335
rxcui: 2044359
rxcui: 2274813
rxcui: 2044367
rxcui: 2044968
rxcui: 2044970
rxcui: 2044363
unii: 21G72T1950
TolvaptanTOLVAPTANTeva Pharmaceuticals, Inc.808a9a1f-2f58-4677-9127-e749ad0070942025-03-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA216933
ndc (package): 0480-3414-14
ndc (package): 0480-4099-11
ndc (package): 0480-3311-14
ndc (package): 0480-3414-66
ndc (package): 0480-3313-14
ndc (package): 0480-3312-66
ndc (package): 0480-4082-11
ndc (package): 0480-3313-66
ndc (package): 0480-3314-66
ndc (package): 0480-3265-11
ndc (package): 0480-3311-66
ndc (package): 0480-3312-14
ndc (package): 0480-3314-14
ndc (package): 0480-4093-11
ndc (package): 0480-3266-11
ndc (product): 0480-3314
ndc (product): 0480-3311
ndc (product): 0480-3414
ndc (product): 0480-3313
ndc (product): 0480-3312
ndc11 (package): 00480331314
rxcui: 2719337
rxcui: 2044966
rxcui: 2274815
rxcui: 2719335
rxcui: 2044359
rxcui: 2274813
rxcui: 2044367
rxcui: 2044968
rxcui: 2044970
rxcui: 2044363
spl id: 55f269ec-f4f3-48c0-a7ea-b5d8a97344d9
spl set id: 808a9a1f-2f58-4677-9127-e749ad007094
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 368GB5141J
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUREnergique, Inc.87c92497-8a51-4977-87fe-e0b4c6bafb192024-09-27WarningsExact identifier
unii: 368GB5141J
EnviroclenzBERBERIS VULGARIS, CARDUUS MARIANUS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, STILLINGIA SYLVATICA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, GERMANIUM SESQUIOXIDE, PHYTOLACCA DECANDRA, ACETONE, AMMONIUM MURIATICUM, BENZINUM, PROPYLENE GLYCOL, SODIUM LAURYL SULFATE, SODIUM TRIPOLYPHOSPHATE, TEREBINTHINA, METHANOL, CHLORINUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUMDeseret Biologicals, Inc.92816bbe-96d6-45fc-9929-d3e6df394a332024-05-02WarningsExact identifier
unii: 368GB5141J
EnvirotoxTRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.BioActive Nutritional, Inc.2b5cfdba-cf4d-4eb0-8c60-20eac69226632024-03-26WarningsExact identifier
unii: 368GB5141J
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHURBioActive Nutritional3382df85-3ec5-4371-830e-4ed345b8f51b2023-07-14WarningsExact identifier
unii: 368GB5141J
PneumotoxTRITICUM AESTIVUM, ALFALFA, ARNICA MONTANA, ASCLEPIAS TUBEROSA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), EUCALYPTUS GLOBULUS, FUCUS VESICULOSUS, HORDEUM VULGARE, IODIUM, NASTURTIUM AQUATICUM, PLANTAGO MAJOR, RAPHANUS SATIVUS, TRIFOLIUM PRATENSE, TRIGONELLA FOENUM-GRAECUM, SYMPHYTUM OFFICINALE, LUNG (SUIS), ORYZA SATIVA, SILICEA, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, NATRUM MURIATICUM, NITRICUM ACIDUM,BioActive Nutritional, Inc.f8846fb1-92e5-4f8e-b3b3-bc620df90a622023-07-12WarningsExact identifier
unii: 368GB5141J
TOLVAPTANTOLVAPTANNovadoz Pharmaceuticals LLC92ce12f1-eae0-4c83-9a4e-a5181e08fa922023-06-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 21G72T1950
Petrochemical DetoxCHELIDONIUM MAJUS, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, SYMPHYTUM OFFICINALE, ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, ARSENICUM ALBUM, CADMIUM SULPHURATUM, GELSEMIUM SEMPERVIRENS, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PLATINUM METALLICUM, LATRODECTUS MACTANSDeseret Biologicals, Inc.b38b492a-cf45-4aa2-ba7e-4573d2c4ebe52023-01-12WarningsExact identifier
unii: 368GB5141J
TolvaptanTOLVAPTANAscend Laboratories, LLCdd71ee70-9435-4715-bee5-edbb5a8d7d7b2022-09-07Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 2044363
unii: 21G72T1950
TolvaptanTOLVAPTANCamber Pharmaceuticals, Inc.6f4c5679-8490-45ec-bd34-1a569e3af8502022-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 21G72T1950

Reported adverse events (FAERS/openFDA)#

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