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 5 of 12 · 231 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PanacodeSYZYGIUM, HYDRASTIS, ADRENALINUM, PANCREATINUM, PITUITARUM POSTERIUM, BOVISTA, INSULIN, LYCOPERSICUM, PHOSPHORICUM AC, PHOSPHORUS, TARENTULA HISPANA, TEREBINTHINA, URANIUM NITRICUMNatural Creations, Incf2144c14-28a2-4dc4-b517-0f81e9c8b7202025-12-16WarningsExact identifier
unii: YKH834O4BH
Chronic Fatigue TherapyEPINEPHRINE, GOLD, CHELIDONIUM MAJUS, ECHINACEA, GINKGO, HELLEBORUS NIGER, PHOSPHORIC ACID, SCUTELLARIA LATERIFLORA, THUJA OCCIDENTALISTRP Company751334b8-f21b-3f94-e053-2a91aa0a9bb92025-12-15WarningsExact identifier
unii: YKH834O4BH
FCS HPEPINEPHRINE,GLUTAMICACID,MUCUNAPRURIENSSEED,NIACINAMIDE,SEROTONIN,UBIDECARENONE,CORTICOTROPIN,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATECRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFURNatural Creations, Inc.ba8fed68-f27f-4651-adec-0994a53758872025-12-10WarningsExact identifier
unii: YKH834O4BH
FCS CPCORTICOTROPIN,GLUTAMICACID,MUCUNAPURIENSSEED,SEROTONIN,EPINEPHRINE,NIACINAMIDE,UBIDECARENONE,ADENOSINETRIPHOSPHATE,INSULINPORK,SUSSCROFAPARATHYROIDGLAND,SUSSCROFAPITUITARYGLAND,THIAMINEHYDROCHLORIDE,THYROID,UNSPECIFIED,ANHYDROUSCITRICACID,HERRINGSPERMDNA,SACCHAROMYCESCEREVISIAERNA,ANACARDIUMOCCIDENTALEFRUIT,ARSENICTRIOXIDE,ASPARTICACID,BARIUMCARBONATE,OYSTERSHELLCALCIUMCARBONATE,CRUDE,CLEMATISRECTAFLOWERINGTOP,LYCOPODIUMCLAVATUMSPORE,ANEMONEPULSATILLA,DATURASTRAMONIUM,SULFURNatural Creations, Inccb69e9d6-62a6-4af0-8d2d-1e68b0830a202025-12-10WarningsExact identifier
unii: YKH834O4BH
Thyroid-AdrenalADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEANewton Laboratories, Inc.b597504a-c667-225c-e053-2a95a90ac7042025-11-25WarningsExact identifier
unii: YKH834O4BH
epinephrineEPINEPHRINEA-S Medication Solutionsa5134e63-9a31-4573-826f-b442d069b3e62025-11-19Warnings, Adverse reactionsExact identifier
application number: NDA020800
rxcui: 1870230
unii: YKH834O4BH
EpinephrineEPINEPHRINEA-S Medication Solutionsab5e23d0-6e99-4647-838d-23a4040602b52025-11-10Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
EPINEPHRINEEPINEPHRINEHenry Schein, Inc.3b1ac82f-6920-4e40-a77e-598398679f2d2025-10-31Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
epinephrineEPINEPHRINEAmneal Pharmaceuticals LLCc0ef05d5-3fc8-4fb4-bf5b-c219ff17b0922025-10-31Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Deluxe Dental Emergency KitEPINEPHRINE, ALBUTEROL SULFATE, NITROGLYCERIN, DIPHENHYDRAMINE HYDROCHLORIDE, ASPIRINBest Dental Kit LLCbae7a52f-504b-416e-afdd-e6853e2d59442025-10-16Warnings, Adverse reactionsExact identifier
rxcui: 1870225
rxcui: 1870230
Basic Dental Emergency KitEPINEPHRINE, ALBUTEROL SULFATE, NITROGLYCERIN, DIPHENHYDRAMINE HYDROCHLORIDE, ASPIRINBest Dental Kit LLC58d78805-3e8c-4859-b2e0-e3089f9252802025-10-16Warnings, Adverse reactionsExact identifier
rxcui: 1870230
EPINEPHRINEEPINEPHRINEMedical Purchasing Solutions, LLC.409581e7-ab70-41f3-e063-6294a90a15dc2025-10-07Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Pollen and Dander LiquescenceALLIUM CEPA, EUPHRASIA OFFICINALIS, ECHINACEA (ANGUSTIFOLIA), SABADILLA, AMBROSIA ARTEMISIAEFOLIA, APIS MELLIFICA, GALIUM APARINE, GLANDULA SUPRARENALIS (BOVINE), HEPAR SUIS, HYDRASTIS CANADENSIS, ADRENALINUM, EPHEDRA VULGARIS, HISTAMINUM HYDROCHLORICUMNutritional Specialties, Inc.395b8a0e-b718-4d6f-9b24-b80119b903482025-10-06WarningsExact identifier
unii: YKH834O4BH
Auvi-QEPINEPHRINEkaleo, Inc6180fb40-7fca-4602-b3da-ce62b8cd24702025-10-02Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
epinephrineEPINEPHRINEASCLEMED USA INC.76f65a94-4b26-4c40-8a74-79a73afbb4e22025-09-04Warnings, Adverse reactionsExact identifier
application number: NDA020800
rxcui: 1870230
unii: YKH834O4BH
EpinephrineEPINEPHRINERedpharm Drug300ac735-4493-c02a-e063-6294a90a5bce2025-08-30Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
EpinephrineEPINEPHRINEProPharma Distribution3d728e53-92c2-114e-e063-6394a90ad4042025-08-28Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Thinnr BOOSTADEPS SUILLUS, ANDRENALINUM, ADRENOCORTICOTROPHIN, CALCAREA CARBONICA, CHELIDONIUM, PITUITARUM, THYROIDINUMSLIMCELL, LLC2bda8ba9-8626-aafd-e063-6294a90adbe82025-08-20WarningsExact identifier
unii: YKH834O4BH
Thinnr PROTOCOLADEPS SUILLUS, ADRENALINIUM, ADRENOCORTICOTROPHIN, AGRIMONIA EUPATORIA FLOS, AMMOUNIUM BROMATUM, ANACARDIUM ORIENTALE, ANTIMONIUM CRUDUM, CASTANEA SATIVA FLOS, CALCAREA CARBONICA, COENZYME A, CORTISONE ACETICUM, FUCUS VESICULOSUS, HYPOTHALAMUS, KALI BICHROMICUM, PITUITARUM POSTERIUM, RNA, SABADILLA, STAPHYSAGRIA, THYROIDINUMSLIMCELL, LLC2c162603-5861-9be0-e063-6294a90ade282025-08-20WarningsExact identifier
unii: YKH834O4BH
TattooTATTOO CREAMPerfso (HK) Co., Limited39773cab-12df-4520-e063-6294a90abc5b2025-07-08WarningsExact identifier
unii: YKH834O4BH

Reported adverse events (FAERS/openFDA)#

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