NDC 0641-6136-01 - Fosphenytoin 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: 0641-6136
Requested NDC: 0641-6136-01
Package NDCs from labels: 0641-6136-01, 0641-6136-25
Manufacturer: Hikma Pharmaceuticals USA Inc.
Effective date: 2024-04-10
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Fosphenytoin Sodium - Hikma Pharmaceuticals USA Inc.	Hikma Pharmaceuticals USA Inc.	2024-04-10	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0641-6136-01	Fosphenytoin Sodium	2 mL in 1 VIAL	INJECTION	2		22
0641-6136-25	Fosphenytoin Sodium	25 in 1 CARTON	INJECTION	25		22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0641-6136	FOSPHENYTOIN SODIUM INJECTION [HIKMA PHARMACEUTICALS USA INC.]	22	Current NDC, Legacy NDC, 2 package rows	20240411_519a44e3-8a93-456c-b71c-894513810d45.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0641-6136-01	ML - Milliliter	0641-6136	a2e1597a-bb1a-47b4-8c77-9118acdd0957	1	2013-09-04
0641-6136-25	ML - Milliliter	0641-6136	d7e833f1-ad63-4075-80ac-ba66e5af44b3	1	2013-09-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FOSPHENYTOIN SODIUM	ACTIVE INGREDIENT	7VLR55452Z	FOSPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	9
PHENYTOIN	ACTIVE MOIETY	6158TKW0C5	FOSPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	9
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	FOSPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	9
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	FOSPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	9
TROMETHAMINE	INACTIVE INGREDIENT	023C2WHX2V	FOSPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	9
WATER	INACTIVE INGREDIENT	059QF0KO0R	FOSPHENYTOIN SODIUM INJECTION [WEST-WARD PHARMACEUTICAL CORP.]	9

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 7 of 11 · 205 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Eyes Alive Eye Wash	WATER	RIVIERA PHARMA INC	081079f4-1c06-4054-b771-00fedaa666f6	2024-06-05	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	Becton Dickinson and Company	6e43c5a3-dad2-49ed-b500-964cb4563cc9	2024-05-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Fatigue Stat CM	ECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, PHYTOLACCA DECANDRA, ARANEA DIADEMA, IPECACUANHA, IRIDIUM METALLICUM, LACHESIS MUTUS, MURIATICUM ACIDUM, RHUS TOX, CYTOMEGALOVIRUS NOSODE	Energique, Inc	aebdb08b-48aa-46f2-930f-f98f5b06a604	2024-05-08	Warnings	Exact identifier unii: QTT17582CB
REFL HS	ADENOSINUM TRIPHOSPHORICUM DINATRUM, NADIDUM, ARGENTUM NITRICUM, IPECACUANHA, ROBINIA PSEUDOACACIA, SULPHUR, ORIGANUM VULGARE, DUODENUM (SUIS), ESOPHAGUS (SUIS), FUNICULUS UMBILICALIS SUIS, STOMACH (SUIS), NUX VOMICA, COUMARINUM, ERYTHRAEA CENTAURIUM, PANCREAS SUIS, MURIATICUM ACIDUM, CITRICUM ACIDUM, FORMICUM ACIDUM, SARCOLACTICUM ACIDUM, COENZYME A, PROTEUS (MORGANI)	Deseret Biologicals, Inc.	83249aee-f58b-442d-9187-6de0cf070e4d	2024-04-29	Warnings	Exact identifier unii: QTT17582CB
PEMF Optimizer	AQUA SULIS, ARGENTUM METALLICUM, AURUM METALLICUM, CUPRUM METALLICUM, LAPIS ALBUS, MANGANUM METALLICUM VANADIUM METALLICUM VISCUM ALBUM, ZINCUM METALLICUM	Deseret Biologicals, Inc.	97d57469-4c5b-4d3f-9398-3a1a6617a649	2024-04-23	Warnings	Exact identifier unii: 059QF0KO0R
EVTOX	COCHLEARIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LOMATIUM DISSECTUM, TABEBUIA IMPETIGINOSA, PROPOLIS, GLANDULA SUPRARENALIS SUIS, THYMUS (SUIS), ARANEA DIADEMA, IPECACUANHA, LYCOPODIUM CLAVATUM, MURIATICUM ACIDUM, NITRICUM ACIDUM, RHUS TOX, SILICEA, EPSTEIN-BARR VIRUS NOSODE	BioActive Nutritional, Inc.	4b518e10-9ce0-492b-92be-6025d8d7c3c6	2024-04-19	Warnings	Exact identifier unii: QTT17582CB
Sterile Water	WATER	Hikma Pharmaceuticals USA Inc.	78ef7ad3-451d-43d0-a9b6-5cf0aadca003	2024-04-10	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Fosphenytoin Sodium	FOSPHENYTOIN SODIUM	Hikma Pharmaceuticals USA Inc.	519a44e3-8a93-456c-b71c-894513810d45	2024-04-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application number: ANDA077989 ndc (package): 0641-6136-01 ndc (package): 0641-6137-10 ndc (package): 0641-6136-25 ndc (package): 0641-6137-01 ndc (product): 0641-6136 ndc (product): 0641-6137 ndc11 (package): 00641613601 rxcui: 1670200 rxcui: 1670195 spl id: d276be92-654c-4912-8dc5-3e148c835523 spl set id: 519a44e3-8a93-456c-b71c-894513810d45 unii: 7VLR55452Z
Sterile Water	WATER	B. Braun Medical Inc.	8fc8d87a-3951-4ac5-97df-c161ffc90475	2024-04-10	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
Eye Wash	WATER	M-star (Hubei) Health&Care Products Co., Ltd.	71706039-e250-4f08-9687-71b2928c4e46	2024-04-01	Warnings	Exact identifier unii: 059QF0KO0R
Oral Health	ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, BORAX, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CANDIDA ALBICANS, CHAMOMILLA, CINCHONA OFFICINALIS, DISCUS INTERVERTEBRALIS SUIS, STREPTOCOCCUS DYSGALACTIAE DNA, STREPTOCOCCUS MUTANS DNA, STREPTOCOCCUS PNEUMONIAE DNA, ECHINACEA PURPUREA, IGNATIA AMARA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MERCURIUS SOLUBILIS, MURIATICUM ACIDUM, NUX MOSCHATA, ORAL MUCOSA (SUIS), OXYGENIUM, SAMBUCUS NIGRA, SEPIA, STAPHYLOCOCCUS AUREUS,	Deseret Biologicals, Inc.	6f66ff40-6e0e-4a35-963c-965c65df76eb	2024-04-01	Warnings	Exact identifier unii: QTT17582CB
ULINE Eyewash	EYEWASH	Uline.	14545fc9-1fb4-befa-e063-6294a90a0474	2024-03-23	Warnings	Exact identifier unii: 059QF0KO0R
Habit	CHAMOMILLA, NATRUM PHOSPHORICUM, VALERIANA OFFICINALIS, PASSIFLORA INCARNATA, ARGENTUM NITRICUM, CALADIUM SEGUINUM, CINCHONA OFFICINALIS, MURIATICUM ACIDUM, SACCHARUM OFFICINALE, AVENA SATIVA, TABACUM, CEREBRUM SUIS, SEROTONIN (HYDROCHLORIDE), ARGEMONE MEXICANA, AGARICUS MUSCARIUS, ARSENICUM ALBUM, AURUM METALLICUM, IPECACUANHA, SEPIA, HYPOTHALAMUS (BOVINE), VIPERA BERUS	Deseret Biologicals, Inc.	3d00a305-e15d-4419-97bd-332421d4a1b0	2024-03-15	Warnings	Exact identifier unii: QTT17582CB
Oral Health	BORAX, BRYONIA (ALBA), ECHINACEA PURPUREA, JUGLANS CINEREA, KALI MURIATICUM, MAGNESIA MURIATICA, MURIATICUM ACIDUM, DISCUS INTERVERTEBRALIS SUIS, ORAL MUCOSA (SUIS), ANTIMONIUM CRUDUM, ARSENICUM ALBUM, BISMUTHUM SUBNITRICUM, CHAMOMILLA, CINCHONA OFFICINALIS, NUX MOSCHATA, SAMBUCUS NIGRA, SEPIA, MERCURIUS SOLUBILIS, CALCAREA PHOSPHORICA, IGNATIA AMARA, OXYGENIUM, CANDIDA ALBICANS, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS MUTANS	Deseret Biologicals, Inc.	81ffb30f-5255-4e16-ba9d-b0de909aa557	2024-03-05	Warnings	Exact identifier unii: QTT17582CB
EPST PLUS	CARDUUS MARIANUS, CISTUS CANADENSIS, DULCAMARA, GALIUM APARINE, MAGNESIA MURIATICA, NATRUM SULPHURICUM, VISCUM ALBUM, MURIATICUM ACIDUM, FOLLICULINUM, AQUA MARINA, AILANTHUS GLANDULOSUS, BARYTA MURIATICA, CADMIUM METALLICUM, CEANOTHUS AMERICANUS, COCCULUS INDICUS, IRIDIUM METALLICUM, THUJA OCCIDENTALIS, CINCHONA OFFICINALIS, CALCAREA CARBONICA, CROTALUS CASCAVELLA	Deseret Biologicals, Inc.	c2bb50a8-e4f9-4af4-aefc-53c9c3cfcc25	2024-02-27	Warnings	Exact identifier unii: QTT17582CB
GI Drainage	CINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOS	Deseret Biologicals, Inc.	ff81e3ca-2f88-4daf-a734-083107269d3a	2024-02-21	Warnings	Exact identifier unii: 059QF0KO0R
Sterile Water	STERILE WATER	Chartwell RX, LLC	3681eeaa-807a-47ca-9fbc-61c2b682800a	2024-02-01		Exact identifier unii: 059QF0KO0R
Sterile Water	WATER	A-S Medication Solutions	dba87371-31d2-47c2-ab83-89aabce4b184	2024-01-31	Warnings, Adverse reactions	Exact identifier unii: 059QF0KO0R
F02 ANGR-FLX	ADELHEID AQUA, ARSENICUM ALBUM, BIG SAGEBRUSH, BOS TAURUS LIVER, GALLBLADDER, BRIZA MAXIMA, CALENDULA OFFICINALIS, CAYENNE, CHAMOMILE , CHICORY , GARLIC, ENGLISH HOLLY , EUROPEAN BEECH , FORKING LARKSPUR , GERMAN CHAMOMILE , IMPATIENS GLANDULIFERA , JUGLANS REGIA , LILIUM TIGRINUM, MORNING GLORY, MOUNTAIN DOGWOOD, NATRUM MURIATICUM, NUX VOMICA, PINUS SYLVESTRIS , REDWOOD, RUBBER RABBITBRUSH, SEPIA, TOLMIE STAR TULIP, VERBENA OFFICINALIS , VITIS VINIFERA , WATERMELON, WHITE WILLOW , YELLOW STAR THISTLE	Apex Energetics Inc.	bc7c2bf3-8b0d-766f-e053-2a95a90ad34c	2024-01-08	Warnings	Exact identifier unii: 059QF0KO0R
F09 LTGO	ADELHEID AQUA, AGRIMONY, MALUS SYLVESTRIS, ARSENICUM ALBUM, FILAREE, HEATHER, HORSE CHESTNUT, LACHESIS MUTUS, NASTURTIUM, RED HORSE CHESTNUT, SEPIA, SILICEA, STRAMONIUM, VERBENA OFFICINALIS	Apex Energetics Inc.	bd1e652f-b3a4-c5bd-e053-2995a90ae03f	2024-01-08	Warnings	Exact identifier unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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