FDA.reportPublic FDA data

NDC 51079-905-01 - Phenytoin 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
51079-905
Requested NDC
51079-905-01
Package NDCs from labels
51079-905-01, 51079-905-20
Manufacturer
Mylan Institutional Inc.
Effective date
2022-06-14
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Phenytoin Sodium - Mylan Institutional Inc.Mylan Institutional Inc.2022-06-14HUMAN PRESCRIPTION DRUG LABEL
Phenytoin Sodium - Cardinal HealthCardinal Health2019-04-23HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2013-02-13Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-905-01EA - Each51079-9059f2e4935-2fd5-4b5b-979e-c59f1d2c0d0a12013-02-13
51079-905-17EA - Each51079-9050542110f-30ae-4fe4-86df-d155eaa3f4ac12013-02-13
51079-905-19EA - Each51079-905672787c6-8af5-4dde-b623-1c109f18ee1012013-02-13
51079-905-20EA - Each51079-905810e26b0-89ec-4ebf-8f59-f9c7b6faee7312013-02-13
51079-905-30EA - Each51079-905ec052ee2-e856-4492-8e13-05c9ac74f19112015-12-02
51079-905-56EA - Each51079-905800d5c7c-bb3a-4041-a145-f4a704998dbe12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
PHENYTOIN SODIUMACTIVE INGREDIENT4182431BJHPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
PHENYTOINACTIVE MOIETY6158TKW0C5PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
GELATININACTIVE INGREDIENT2G86QN327LPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
GELATININACTIVE INGREDIENT2G86QN327LPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN16PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
HYDROXYETHYL CELLULOSE (2000 MPA.S AT 1%)INACTIVE INGREDIENTS38J6RZN16PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
SHELLACINACTIVE INGREDIENT46N107B71OPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
SHELLACINACTIVE INGREDIENT46N107B71OPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4PHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [MYLAN INSTITUTIONAL INC.]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPHENYTOIN SODIUM CAPSULE, EXTENDED RELEASE [CARDINAL HEALTH]5

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 144 · 2,867 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Incd2d1428a-c8b5-9529-e053-2995a90a23432026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
S12 AIRBORNEALFALFA, ALLIUM SATIVUM, ARSENICUM IODATUM, BARLEY, BETULA PUBESCENS, BROWN RICE, CORN GRAIN, EUPHRASIA OFFICINALIS, FEATHER MIX, HAIR MIX, HISTAMINUM, HOUSE DUST MITE, LOLIUM PERENNE, OAT, PERFOLIATE HONEYSUCKLE, PHLEUM PRATENSE, POLLEN MIX, RYE, SABADILLA, SILICEA, SKIN MIX, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TEREBINTHINA, WHEATApex Energetics Inc.bb0036c3-1e4d-5750-e053-2995a90ae8952026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Aging Eye FormulaCINERARIA MARITIMA, EYE (SUIS), CALCAREA FLUORICA, CAUSTICUM, PHOSPHORUS, SILICEA, ZINCUM METALLICUM, GERMANIUM METALLICUM, NATRUM MURIATICUMNutritional Specialties, Inc.d5b44f79-5299-4b31-ba45-0e511cdbe17c2026-08-24WarningsExact identifier
unii: ETJ7Z6XBU4
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
Bio Combination 28SCHUESSLER SALTSLDD Bioscience Private Limited597caf33-5107-9dec-e063-6294a90a5fcd2026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Psorinum ComplexPHOSPHORUS, SILICEA, SULPHUR, ALOEBioActive Nutritional, Inc.d4746927-e6d4-463d-a084-56ffc48d1e672026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4
Boneforce HPCALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, HYDROFLUORICUM ACIDUM, RHUS TOX, SILICEA, SYMPHYTUM OFFICINALEBioActive Nutritional, Inc.d96ca52b-781d-431c-ad2a-a54fd57eb1062026-08-20WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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