FDA.reportPublic FDA data

NDC 58005-004 - EPINEPHRINE

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
58005-004
Package NDCs from labels
58005-004-02
Manufacturer
Sparhawk Laboratories, Inc.
Effective date
2022-05-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
EPINEPHRINE INJECTIONSparhawk Laboratories, Inc.2022-05-25PRESCRIPTION ANIMAL DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58005-004-02EPINEPHRINE50 mL in 1 VIALINJECTION509

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58005-004EPINEPHRINE INJECTION [SPARHAWK LABORATORIES, INC.]91 package rows20220526_54a9cdee-791c-4eee-8d99-71a11213e9dc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPINEPHRINEACTIVE INGREDIENTYKH834O4BHEPINEPHRINE INJECTION [SPARHAWK LABORATORIES, INC.]4
EPINEPHRINEACTIVE MOIETYYKH834O4BHEPINEPHRINE INJECTION [SPARHAWK LABORATORIES, INC.]4
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KEPINEPHRINE INJECTION [SPARHAWK LABORATORIES, INC.]4

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 10 of 12 · 231 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AdrenalinumEPINEPHRINEBoiron84b2e61b-7c92-5a2e-e053-2a91aa0a626c2023-07-12Exact identifier
unii: YKH834O4BH
Hypercalm-Mental FocusCHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDENewton Laboratories, Inc.ff5f22e1-74ee-1eee-e053-6394a90a26782023-06-30WarningsExact identifier
unii: YKH834O4BH
Hypercalm-Mental FocusCHAMOMILLA, ECHINACEA, HYPERICUM PERFORATUM, PASSIFLORA INCARNATA, ACONITUM NAPELLUS, ADRENALINUM, ARGENTUM NIT., ARSENICUM ALBUM, BAPTISIA TINCTORIA, CHAMOMILLA, COFFEA CRUDA, CYPRIPEDIUM PUBESCENS, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, HUMULUS LUPULUS, HYOSCYAMUS NIGER, IGNATIA AMARA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS MUTUS, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, SCUTELLARIA LATERIFLORA, STAPHYSAGRIA, STRAMONIUM, THERIDION, VERATRUM VIRIDENewton Laboratories, Inc.ff604442-4697-e2bb-e053-6394a90a03402023-06-30WarningsExact identifier
unii: YKH834O4BH
Hyperactivity-Mental FocusADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORANewton Laboratories, Inc.fecece1f-22bc-21dc-e053-6294a90ad0c32023-06-23WarningsExact identifier
unii: YKH834O4BH
Hyperactivity-Mental FocusADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORANewton Laboratories, Inc.fed03a1c-0ea8-1f8e-e053-6394a90a04c02023-06-23WarningsExact identifier
unii: YKH834O4BH
Hyperactivity-Mental FocusADRENALINUM, ACONITUM NAP., ARG. NIT., ARSENICUM ALB., BAPTISIA, CHAMOMILLA, CYPRIPEDIUM, DIGITALIS, GELSEMIUM, HUMULUS, IGNATIA, IMPATIENS GLANDULIFERA FLOS, IODIUM, LACHESIS, LYCOPODIUM, NAT. MUR., NUX VOM., SCUTELLARIA LATERIFLORA, STAPHYSAG., STRAMONIUM, THERIDION, ECHINACEA, GINGKO, HYPERICUM, PASSIFLORANewton Laboratories, Inc.febf610e-e08a-4797-e053-6294a90a3eb52023-06-22WarningsExact identifier
unii: YKH834O4BH
AllerforceCHONDRUS CRISPUS, GLYCYRRHIZA GLABRA, SARSAPARILLA, ZINGIBER OFFICINALE, ADRENALINUM, ALLIUM CEPA, ARALIA RACEMOSA, ARSENICUM ALBUM, CALCAREA CARBONICA, CANTHARIS, IODIUM, NATRUM CARBONICUM, RHUS TOX,BioActive Nutritional, Inc.667036a4-2a89-45c3-a7cc-4b37d735fa4a2023-06-05WarningsExact identifier
unii: YKH834O4BH
Allergen IIPOTASSIUM GLUCONATE, ADRENALINUM, HEPAR BOVINE, ARSENICUM ALBUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SULPHUR, AMBROSIA ARTEMISIAEFOLIA, KENTUCKY BLUEGRASS, ORCHARD GRASS, BERMUDA GRASS, JOHNSON GRASS, RYE GRASS, VERNAL GRASS, BAHIA GRASS, TIMOTHY GRASS, HISTAMINUM HYDROCHLORICUMBioActive Nutritional, Inc.2140b105-60d6-4b52-82f5-407211fd69332023-06-05WarningsExact identifier
unii: YKH834O4BH
EpinephrineEPINEPHRINEMedical Purchasing Solutions, LLC6bce7d5c-bb6b-1f36-e053-2a91aa0a68ab2023-05-22Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
EpinephrineEPINEPHRINEMedical Purchasing Solutions, LLC6bdca08a-65bf-f56c-e053-2a91aa0a56d82023-05-22Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Histastat PollenBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), ADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SABADILLA, SINAPIS NIGRA, SOLIDAGO VIRGAUREA, SULPHUR, WYETHIA HELENIOIDESEnergique, Inc.00478787-ccec-4101-a0da-fd337037c3ee2023-05-12WarningsExact identifier
unii: YKH834O4BH
HBPRUTA GRAVEOLENS, VALERIANA OFFICINALIS, ADRENALINUM, ARSENICUM IODATUM, AURUM METALLICUM, BARYTA CARBONICA, BRYONIA, CACTUS GRANDIFLORUS, CHELIDONIUM MAJUS, CINCHONA OFFICINALIS, CROTALUS HORRIDUS, DIGITALIS PURPUREA, GLONOINUM, KALI CARBONICUM, KALI IODATUM, LACHESIS MUTUS, NAJA TRIPUDIANS, NUX VOMICA, VERATRUM ALBUM, VIPERA BERUS, VISCUM ALBUM, ELAPS CORALLINUS.Newton Laboratories, Inc.fb453b29-ffdf-bc31-e053-6394a90ab7f92023-05-09WarningsExact identifier
unii: YKH834O4BH
AdrenalinEPINEPHRINEMedical Purchasing Solutions, LLCb622a9b9-2f09-46e4-e053-2995a90aae012023-05-04Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
EPINEPHRINEEPINEPHRINEMedical Purchasing Solutions, LLCc4327095-3a89-d86a-e053-2a95a90ac2552023-04-27Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Auvi-QEPINEPHRINEMedical Purchasing Solutions, LLC8f110633-bf37-458d-e053-2a95a90a8fa92023-04-26Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Auvi-QEPINEPHRINEMedical Purchasing Solutions, LLC8f00231e-be88-49fe-e053-2a95a90ab6dd2023-04-26Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Neuro T Support LiquescenceALFALFA, BANANA, VALERIANA OFFICINALIS, CHOLINUM, GABA (GAMMA AMINOBUTYRIC ACID), INOSITOL, OLEANDER, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, PINEAL GLAND (SUIS), SCUTELLARIA LATERIFLORA, ACETYLCHOLINE CHLORIDE, NOREPINEPHRINE (BITARTRATE), CADMIUM METALLICUM, DOPAMINE (HYDROCHLORIDE), SEROTONIN (HYDROCHLORIDE), ADRENALINUMNutritional Specialties, Inc.727f168a-6d9c-4ff5-b161-8bf0642a117b2023-04-25WarningsExact identifier
unii: YKH834O4BH
EpinephrineEPINEPHRINEAmerican Regent, Inc.61cacda5-64ee-45ca-b94c-e8640c43e5812023-04-01Warnings, Adverse reactionsExact identifier
rxcui: 310132
unii: YKH834O4BH
Metabolic Correction BlendFOENICULUM VULGARE, AMMONIUM BROMATUM, FUCUS VESICULOSUS, LECITHIN (DERIVED FROM EGG), CAPSICUM ANNUUM, GALIUM APARINE, HYPOTHALAMUS SUIS, KALI BICHROMICUM, LAC DEFLORATUM (NSPC), PHYTOLACCA DECANDRA, PROGESTERONE, THYROIDINUM (BOVINE), PITUITARUM POSTERIUM (BOVINE), ANTIMONIUM CRUDUM, ARGENTUM METALLICUM, CALCAREA CARBONICA, FERRUM METALLICUM, GRAPHITES, ADRENALINUM, PHOSPHORUSIHA Distribution, LLCe8ec4f7e-c9dd-46dd-a9ee-2b8b7bcea9a82023-03-21WarningsExact identifier
unii: YKH834O4BH
EPIPENEPINEPHRINEViatris Specialty LLC7560c201-9246-487c-a13b-6295db04274a2023-02-15Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH

Reported adverse events (FAERS/openFDA)#

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