FDA.reportPublic FDA data

NDC 80425-0264-01 - 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
80425-0264
Requested NDC
80425-0264-01
Package NDCs from labels
80425-0264-1, 80425-0264-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Epinephrine - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0264-1Epinephrine1 in 1 CASEINJECTION12
80425-0264-1Epinephrine2 in 1 CARTONINJECTION22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0264EPINEPHRINE INJECTION [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 2 package rows20250102_f4d7aca4-0acd-74c2-e053-2995a90a9d94.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0264-1EA - Each80425-0264600e8451-1349-4ca8-92e9-a1115d09fc9312023-04-07

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 2 of 12 · 231 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FNG IIECHINACEA (ANGUSTIFOLIA), LOMATIUM DISSECTUM, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, HYDRASTIS CANADENSIS, IODIUM, ADRENALINUM, ARGENTUM METALLICUM, THYMUS (SUIS), THYROIDINUM (SUIS), PHOSPHORICUM ACIDUM, CANDIDA ALBICANS, LYCOPODIUM CLAVATUM, PULSATILLA (VULGARIS), SEPIABioActive Nutritional, Inc.d15cbfe9-051d-4aeb-a0f3-105bef7796bc2026-05-07WarningsExact identifier
unii: YKH834O4BH
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEHenry Schein, Inc.5569d607-f1cb-4f1d-8a00-d50433ec05d32026-05-07Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Emotional Detox and DrainageACONITUM NAPELLUS, ADRENALINUM, AMBRA GRISEA, AURUM MURIATICUM NATRONATUM, CALCAREA SULPHURICA, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, CORTISONE ACETICUM, CROCUS SATIVUS, DNA, HYOSCYAMUS NIGER, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, IGNATIA AMARA, KALI BROMATUM, LACHESIS MUTUS, PULSATILLA (PRATENSIS), THYROIDINUM (BOVINE), VIOLA ODORATADeseret Biologicals, Inc.468a3923-2b66-4f2d-9af2-c911ed1d33072026-05-06WarningsExact identifier
unii: YKH834O4BH
EpinephrineEPINEPHRINEHikma Pharmaceuticals USA Inc.1e8ebac1-5b32-47f9-a930-86a98a24dccc2026-05-05Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Pollen HayfeverADRENALINUM, ALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARSENICUM IODATUM, MUGWORT POLLEN (ARTEMISIA VULGARIS), BELLIS PERENNIS, BRASSICA SPP, CHENOPODIUM ALBUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, ALFALFA POLLEN (MEDICAGO SATIVA), PHLEUM PRATENSE, YELLOW DOCK POLLEN (RUMEX CRISPUS), SABADILLA, SILICEA, GOLDENROD POLLEN (SOLIDAGO CANADENSIS), DANDELION POLLEN (TARAXACUM OFFICINALE), RED CLOVER POLLEN (TRIFOLIUM PRATENSE), XANTHIUM STRUMARIUMNaturalCare00665933-176e-4f16-b6ee-b55217b8abb32026-05-05WarningsExact identifier
unii: YKH834O4BH
EpinephrineEPINEPHRINESportpharm LLC3a8f5ca2-6c1d-4011-9266-ba93c7a3abb92026-04-24Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
neffyEPINEPHRINESportpharm LLC2052f9db-7d76-443b-b702-b6b499f9a4b82026-04-24Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINESportpharm LLC2c58deba-dbb2-4e73-a173-36053536f03e2026-04-22Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINEHenry Schein, Inc.c3490a23-14c4-43f7-b066-96a4c4298fde2026-04-14Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Animal Hair and DanderADRENALINUM, ALLIUM CEPA, ARSENICUM IODATUM, CAT (DANDER), DOG (DANDER), EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, SABADILLA, SHEEP WOOL, SILICEANaturalCaref0067255-9310-43a0-b415-c03a0f554bcc2026-04-10WarningsExact identifier
unii: YKH834O4BH
neffyEPINEPHRINEARS Pharmaceuticals Operations, Inc.a1758142-a905-401d-8961-05829f51023a2026-04-09Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
AdrenalinEPINEPHRINEPar Health USA, LLCa5ce0c01-dd47-4997-ab09-490de65d38352026-04-08Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
AdrenalinEPINEPHRINEPar Health USA, LLCb27e06aa-5b40-44bc-8de7-80b027580a3b2026-04-08Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
CirculationNIACIN, NICOTINAMIDUM, ARNICA MONTANA, CAMPHORA, NUX VOMICA, STROPHANTHUS HISPIDUS, VERATRUM ALBUM, ADRENALINUM, AESCULUS HIPPOCASTANUM, AURUM METALLICUM, GELSEMIUM SEMPERVIRENS, HELODERMA (HORRIDUS), RHUS TOX, TABACUMNutritional Specialties, Inc.220bbbf3-d54d-4222-b540-e197927ab8bc2026-04-01WarningsExact identifier
unii: YKH834O4BH
Endoplex FCIMICIFUGA RACEMOSA, FUCUS VESICULOSUS, GLYCYRRHIZA GLABRA, XANTHOXYLUM FRAXINEUM, ADRENALINUM, CEREBRUM SUIS, HYPOPHYSIS SUIS, HYPOTHALAMUS (SUIS), OOPHORINUM (SUIS), PINEAL (SUIS), THYROIDINUM (SUIS), PULSATILLA (VULGARIS), SEPIABioActive Nutritional, Inc.bfe6d42a-a3e5-44b3-ab8f-b08ad4e2b66f2026-03-30WarningsExact identifier
unii: YKH834O4BH
epinephrineEPINEPHRINEBaxter Healthcare Corporationef556382-9d19-4f0e-9dbe-fcecc772a3e22026-03-30Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
epinephrineEPINEPHRINEREMEDYREPACK INC.c66de0d3-3b0f-4e52-a712-60357a1076762026-03-24Warnings, Adverse reactionsExact identifier
application number: NDA020800
rxcui: 1870230
unii: YKH834O4BH
Emotional Detox and DrainageACONITUM NAPELLUS, ADRENALINUM, AMBRA GRISEA, AURUM MURIATICUM NATRONATUM, CALCAREA SULPHURICA, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, CORTISONE ACETICUM, CROCUS SATIVUS, DNA, HYOSCYAMUS NIGER, HYPOPHYSIS SUIS, HYPOTHALAMUS SUIS, IGNATIA AMARA, KALI BROMATUM, LACHESIS MUTUS, PULSATILLA (PRATENSIS), THYROIDINUM (BOVINE), VIOLA ODORATADeseret Biologicals, Inc.6b553600-5a90-4014-b02a-0992562bd2292026-03-20WarningsExact identifier
unii: YKH834O4BH
epinephrineEPINEPHRINEAmneal Pharmaceuticals of New York LLCe13f05f1-7d21-49bb-b8d5-24bf9301c3d72026-03-20Warnings, Adverse reactionsExact identifier
application number: NDA020800
ndc (product): 0115-1694
rxcui: 1870225
rxcui: 1870230
spl id: fdafd090-bed3-4f16-8ab1-fd1573aa633e
spl set id: e13f05f1-7d21-49bb-b8d5-24bf9301c3d7
unii: YKH834O4BH
Grass PollenADRENALINUM, ALLIUM CEPA, ARSENICUM IODATUM, OATS (AVENA SATIVA), BROME GRASS (BROMUS INERMIS), BERMUDA GRASS (CYNODON DACTYLON), ORCHARD GRASS (DACTYLIS GLOMERATA), EUPHRASIA OFFICINALIS, MEADOW GRASS (FESTUCA ELATIOR PRATENSIS), HISTAMINUM HYDROCHLORICUM, PERENNIAL RYE GRASS (LOLIUM PERENNE), TIMOTHY GRASS (PHLEUM PRATENSE), SABADILLA, SANGUINARIA CANADENSIS, RYE GRASS (SECALE CEREALE), JOHNSON GRASS (SORGHUM HALEPENSE), WHEAT GRASS (TRITICUM AESTIVUM), CORN (ZEA MAYS)NaturalCare81f7c49e-b4da-4815-b66a-67b63193d1dd2026-03-10WarningsExact identifier
unii: YKH834O4BH

Reported adverse events (FAERS/openFDA)#

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