FDA.reportPublic FDA data

NDC 0591-5778 - Atenolol

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
0591-5778
Package NDCs from labels
0591-5778-01
Manufacturer
Rebel Distributors Corp.
Effective date
2009-06-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Atenolol Tablets, USPRebel Distributors Corp.2009-06-01HUMAN PRESCRIPTION DRUG LABEL
Atenolol Tablets USP Revised: April 2006 Rx onlyWatson Laboratories, Inc.2007-03-02HUMAN PRESCRIPTION DRUG LABELING
Atenolol Tablets USP Rx onlyWatson Laboratories, Inc.2006-03-08HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-5778-01Atenolol100 in 1 BOTTLETABLET1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5778ATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]11 package rows20070309_A32ECCC4-16D1-47A5-9E61-261F5D38638C.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AtenololACTIVE INGREDIENT50VV3VW0TIATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
ATENOLOLACTIVE INGREDIENT50VV3VW0TIATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]1
AtenololACTIVE INGREDIENT50VV3VW0TIATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
AtenololACTIVE MOIETY50VV3VW0TIATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
ATENOLOLACTIVE MOIETY50VV3VW0TIATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]1
AtenololACTIVE MOIETY50VV3VW0TIATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM CARBONATEINACTIVE INGREDIENT0E53J927NAATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30ATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
microcrystalline celluloseINACTIVE INGREDIENTATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
microcrystalline celluloseINACTIVE INGREDIENTATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
povidoneINACTIVE INGREDIENTATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
povidoneINACTIVE INGREDIENTATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]1
sodium starch glycolateINACTIVE INGREDIENTATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
sodium starch glycolateINACTIVE INGREDIENTATENOLOL (ATENOLOL) TABLET [WATSON LABORATORIES, INC.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJATENOLOL TABLET [REBEL DISTRIBUTORS CORP.]1

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 31 of 40 · 785 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
R16 BRONCHIADENOSINE TRIPHOSPHATE, CALCAREA IODATA, CUPRUM METALLICUM, IGNATIA AMARA, PLATINUM METALLICUM, SILICEA, THUJA OCCIDENTALISApex Energetics Inc.c0f759b1-d7f8-12b3-e053-2a95a90a87682024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
N09 BACTEROTOXACONITUM NAPELLUS, ALLIUM CEPA, ALLIUM SATIVUM, BELLADONNA, CALCAREA SULPHURICA, CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, FERRUM PHOSPHORICUM, CALCIUM SULFIDE, HYDRASTIS CANADENSIS, LACHESIS MUTUS, MYRISTICA SEBIFERA, SILICEA, THUJA OCCIDENTALISApex Energetics Inc.ba99bb1e-c36f-8bf8-e053-2995a90ac3082024-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
DV HPCALCAREA CARBONICA, CHENOPODIUM ANTHELMINTICUM, COCCULUS INDICUS, CONIUM MACULATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEABioActive Nutritional, Inc.74bda12d-5e3d-4f52-9e3f-98012c92fc912024-01-05WarningsExact identifier
unii: ETJ7Z6XBU4
LymphdrainexGERANIUM ROBERTIANUM, NASTURTIUM AQUATICUM, TEUCRIUM SCORODONIA, EQUISETUM HYEMALE, FUMARIA OFFICINALIS, NATRUM SULPHURICUM, PHYTOLACCA DECANDRA, PINUS SYLVESTRIS, VERONICA OFFICINALIS, BAPTISIA TINCTORIA, GALIUM APARINE, GENTIANA LUTEA, APIS MELLIFICA, SARSAPARILLA (SMILAX REGELII), BARYTA CARBONICA, HEPAR SULPHURIS CALCAREUM, MERCURIUS CYANATUS, SCROPHULARIA NODOSA, ALOE, FERRUM IODATUM, MYOSOTIS ARVENSIS, ARANEA DIADEMA, CALCAREA PHOSPHORICA, JUGLANS REGIA, PARATHYROID GLAND (BOVINE), SILICEA,Energique, Inc.22c8f143-1c23-4a10-9577-2adc03f1b6b22023-12-28WarningsExact identifier
unii: ETJ7Z6XBU4
AtenololATENOLOLA-S Medication Solutionsd73a475a-c8c9-44a0-89ac-6a2d665c0d242023-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 50VV3VW0TI
Humco Dewees CarminativeMAGNESIUM CARBONATEHumco Holding Group, inc.163bceeb-ca74-413e-88b9-5c7bc9bbeb0d2023-12-15WarningsExact identifier
unii: 0E53J927NA
INONALUMINUM HYDROXIDE, MAGNESIUM CARBONATE, SODIUM BICARBONATESato Pharmaceutical Co., Ltd.e86d9c57-c877-49f1-a405-95a9a226ccf32023-12-04WarningsExact identifier
unii: 0E53J927NA
AtenololATENOLOLA-S Medication Solutionsa0e3b2a5-5ea1-4549-8144-bd059f7966f02023-12-03Warnings, Adverse reactionsExact identifier
rxcui: 197379
unii: 50VV3VW0TI
AtenololATENOLOLA-S Medication Solutions98471493-56ee-47a4-9120-0975c265361e2023-12-03Warnings, Adverse reactionsExact identifier
rxcui: 197381
unii: 50VV3VW0TI
Aluminum hydroxide and Magnesium carbonateALUMINUM HYDROXIDE, MAGNESIUM CARBONATESimpex Pharma Pvt. Ltde799a555-bfd0-4298-a5dc-aeb671815d402023-11-29WarningsExact identifier
unii: 0E53J927NA
TerrestristatALFALFA, AVENA SATIVA, FUCUS VESICULOSUS, ARALIA QUINQUEFOLIA, NATRUM CARBONICUM, THYROIDINUM (SUIS), CEREBRUM SUIS, PINEAL GLAND (SUIS), RHODODENDRON CHRYSANTHUM, AGATE, ARGENTUM NITRICUM, CADMIUM IODATUM, CALCAREA PHOSPHORICA, COFFEA CRUDA, CUPRUM METALLICUM, MERCURIUS CORROSIVUS, PHOSPHORICUM ACIDUM, PHOSPHORUS, QUARTZ, SILICEA, STRONTIUM CARBONICUM, RADIUM BROMATUM, CARCINOSIN, TARENTULA CUBENSIS, X-RAY, HOLMIUM METALLICUM, URANIUM NITRICUM.Energique, Inc.9bd83312-6872-4e39-b7ff-bbeb69015d802023-11-17WarningsExact identifier
unii: ETJ7Z6XBU4
Silica marinaSILICON DIOXIDEBoiron81442e86-bef4-4992-e053-2a91aa0a24532023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d2b8f2-dce0-c136-e053-2991aa0a0fdb2023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d31d98-dd71-870e-e053-2991aa0a0ce72023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3ffad-5be4-700a-e053-2991aa0a1cc92023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3206e-a893-3f0c-e053-2991aa0a149f2023-11-15Exact identifier
unii: ETJ7Z6XBU4
SiliceaSILICON DIOXIDEBoiron86d3d6ca-8b63-2e63-e053-2991aa0a0e052023-11-15Exact identifier
unii: ETJ7Z6XBU4
Magnesia carbonicaMAGNESIUM CARBONATEBoiron862e048c-eb6f-a3b7-e053-2991aa0accf42023-11-14Exact identifier
unii: 0E53J927NA
Magnesia carbonicaMAGNESIUM CARBONATEBoiron862e9b31-48b5-2067-e053-2991aa0ac1112023-11-14Exact identifier
unii: 0E53J927NA
Magnesia carbonicaMAGNESIUM CARBONATEBoiron862e9b31-48c3-2067-e053-2991aa0ac1112023-11-14Exact identifier
unii: 0E53J927NA

Reported adverse events (FAERS/openFDA)#

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