NDC 59115-002-99 - Naproxen Sodium

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
59115-002
Requested NDC
59115-002-99
Package NDCs from labels
59115-002-99
Manufacturer
Hikma Pharmaceutical | Al Hikma Pharmaceuticals LLC
Effective date
2012-07-16
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Naproxen Sodium - Hikma Pharmaceutical | Al Hikma Pharmaceuticals LLCHikma Pharmaceutical | Al Hikma Pharmaceuticals LLC2012-07-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
NAPROXEN SODIUMACTIVE INGREDIENT9TN87S3A3CNAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]3
NAPROXENACTIVE MOIETY57Y76R9ATQNAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UNAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]3
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]3
POVIDONEINACTIVE INGREDIENTFZ989GH94ENAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JNAPROXEN SODIUM TABLET [HIKMA PHARMACEUTICAL]3

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 39 of 47 · 934 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Naproxen SodiumNAPROXEN SODIUMStrategic Sourcing Services LLC435e55b2-3d75-4a1e-9f00-69b29baf37af2023-10-02WarningsExact identifier
unii: 9TN87S3A3C
BHI MigraineACETIC ACID, ARANEUS DIADEMATUS, ASAFETIDA, BRYONIA ALBA WHOLE, TRIBASIC CALCIUM PHOSPHATE, ACTIVATED CHARCOAL, CINCHONA OFFICINALIS BARK, MARSDENIA CONDURANGO BARK, TUBOCURARINE CHLORIDE, KALMIA LATIFOLIA LEAF, LYCOPODIUM CLAVATUM SPORE, SODIUM SULFATE, PHOSPHORIC ACID, PULSATILLA VULGARIS, CLAVICEPS PURPUREA SCLEROTIUM, AND SILICON DIOXIDEMediNatura Inc11cad8ba-6914-420e-bab0-4ca37d33f2e62023-09-28WarningsExact identifier
unii: ETJ7Z6XBU4
ZeelALPHA LIPOIC ACID, ARNICA MONTANA WHOLE,SUS SCROFA CARTILAGE, COENZYME A,SOLANUM DULCAMARA TOP,SUS SCROFA EMBRYO,SUS SCROFA UMBILICAL CORD, NADIDE, SODIUM DIETHYL OXALACETATE,SUS SCROFA PLACENTA,TOXICODENDRON PUBESCENS LEAF, SANGUINARIA CANADENSIS ROOT, SILICON DIOXIDE,SULFUR,CORIANDERBiologische Heilmittel Heeld5d7a2e5-a6ce-4a41-9430-1378023aa7d02023-09-28WarningsExact identifier
unii: ETJ7Z6XBU4
NAPROXEN SODIUMNAPROXEN SODIUMTIME CAP LABORATORIES, INCab7b7b8e-923b-4dc1-812c-78e85de1bee12023-09-13WarningsExact identifier
unii: 9TN87S3A3C
Stomach DistressBISMUTHUM SUBNITRICUM, CALCAREA SULPHURICA, CARBO ANIMALIS, CARBO VEGETABILIS, CINCHONA OFFICINALIS, HYDRASTIS CANADENSIS, NUX VOMICA, ORNITHOGALUM UMBELLATUM, PYROGENIUM, SILICEA,Liddell Laboratories, Inc.4c764fbe-2fbf-4f06-9ad5-824373c6929a2023-09-11WarningsExact identifier
unii: ETJ7Z6XBU4
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: ETJ7Z6XBU4
MEB Puri-vegaMEB PURI-VEGAKadesh Incoporation Co,Ltd03865989-3034-10fc-e063-6394a90ac80b2023-09-05WarningsExact identifier
unii: ETJ7Z6XBU4
Anubis Barcelona Protective LineETHYLHEXYL METHOXYCINNAMATE, BUTYL METHOXYDIBENZOYLMETHANE, ETHYLHEXYL SALICYLATE, OCTOCRYLENEANUBIS COSMETICS SLec83846f-11c0-8f59-e053-2995a90ab9d22023-09-01WarningsExact identifier
unii: ETJ7Z6XBU4
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
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
naproxen sodiumNAPROXEN SODIUMCVS Pharmacyf246ff56-23e4-4d39-9d73-7c0dd2b99fd32023-08-22WarningsExact identifier
unii: 9TN87S3A3C
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
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
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
NaproxenNAPROXEN SODIUMProficient Rx LP2acd8e24-449d-4f5c-9323-504013ff4bf52023-07-28WarningsExact identifier
unii: 9TN87S3A3C
MEB Puri-MegaMEB PURI-MEGAKadesh Incoporation Co,Ltd018125f2-ad4b-b38a-e063-6294a90a7f6e2023-07-27WarningsExact identifier
unii: ETJ7Z6XBU4
VACC HCHEPAR SUIS, HISTAMINUM HYDROCHLORICUM, THUJA OCCIDENTALIS, RNA, ECHINACEA (ANGUSTIFOLIA), LEDUM PALUSTRE, MEZEREUM, SILICEA, INFLUENZINUM (2021-2022), ANTIMONIUM TARTARICUM, ARSENICUM ALBUM, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, HYOSCYAMUS NIGER, LAC FELINUM, MERCURIUS SOLUBILIS, NICOTINAMIDUM, SENEGA OFFICINALIS, SPIGELIA ANTHELMIA, SULPHUR, ZINCUM METALLICUMDeseret Biologicals, Inc.c100d87b-4d67-42ef-b7e2-fd3642a104b82023-07-18WarningsExact identifier
unii: ETJ7Z6XBU4
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
SiliceaSILICEARatis, LLC8c2b59e1-9936-486c-9a91-153e46f377e62023-07-13WarningsExact identifier
unii: ETJ7Z6XBU4
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: ETJ7Z6XBU4
unii: 368GB5141J

Reported adverse events (FAERS/openFDA)#

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