FDA.reportPublic FDA data

NDC 49502-500-01 - EPIPEN

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
49502-500
Requested NDC
49502-500-01
Package NDCs from labels
49502-500-01, 49502-500-02, 49502-500-92
Manufacturer
REMEDYREPACK INC.
Effective date
2024-02-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
EPIPEN - REMEDYREPACK INC.REMEDYREPACK INC.2024-02-15HUMAN PRESCRIPTION DRUG LABEL
EPIPEN - Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEMAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2023-08-29HUMAN PRESCRIPTION DRUG LABEL
EPIPEN - Viatris Specialty LLCViatris Specialty LLC2023-02-15HUMAN PRESCRIPTION DRUG LABEL
EPINEPHRINE - HF Acquisition Co LLC, DBA HealthFirstHF Acquisition Co LLC, DBA HealthFirst2022-12-09HUMAN PRESCRIPTION DRUG LABEL
EPIPEN - TYA PharmaceuticalsTYA Pharmaceuticals2014-05-01HUMAN PRESCRIPTION DRUG LABEL
EpiPen - Dispensing Solutions, Inc. | PSS World Medical, Inc.Dispensing Solutions, Inc. | PSS World Medical, Inc.2012-09-25HUMAN PRESCRIPTION DRUG LABEL
EpiPen - Physicians Total Care, Inc.Physicians Total Care, Inc.2012-05-14HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49502-500-01EPIPEN0.3 mL in 1 SYRINGE, GLASSINJECTION0.337
49502-500-01EPIPEN1 in 1 CONTAINERINJECTION137
49502-500-02EPIPEN2 in 1 CARTONINJECTION237
49502-500-92EPIPEN2 in 1 CARTONINJECTION237
49502-500-92EPIPEN1 in 1 CONTAINERINJECTION137

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49502-500EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [VIATRIS SPECIALTY LLC]37Current NDC, Legacy NDC, 5 package rows20250212_7560c201-9246-487c-a13b-6295db04274a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49502-500-01EA - Each49502-500b7a3a225-9ccd-4d53-a858-8a284a69d25712022-09-12
49502-500-02EA - Each49502-500942cabcc-475f-4c52-a017-9960981c7d2412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
EPINEPHRINEACTIVE INGREDIENTYKH834O4BHEPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [MYLAN SPECIALTY L.P.]13
EPINEPHRINEACTIVE MOIETYYKH834O4BHEPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [MYLAN SPECIALTY L.P.]13
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBEPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [MYLAN SPECIALTY L.P.]13
NITROGENINACTIVE INGREDIENTN762921K75EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [MYLAN SPECIALTY L.P.]13
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XEPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [MYLAN SPECIALTY L.P.]13
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CEPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [MYLAN SPECIALTY L.P.]13
WATERINACTIVE INGREDIENT059QF0KO0REPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [MYLAN SPECIALTY L.P.]13
EPINEPHRINEACTIVE INGREDIENTYKH834O4BHEPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [TYA PHARMACEUTICALS]4
EPINEPHRINEACTIVE MOIETYYKH834O4BHEPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [TYA PHARMACEUTICALS]4
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBEPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [TYA PHARMACEUTICALS]4
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XEPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [TYA PHARMACEUTICALS]4
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CEPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [TYA PHARMACEUTICALS]4
EpinephrineACTIVE INGREDIENTYKH834O4BHEPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]2
EPINEPHRINEACTIVE INGREDIENTYKH834O4BHEPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [PHYSICIANS TOTAL CARE, INC.]2
EpinephrineACTIVE MOIETYYKH834O4BHEPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]2
EPINEPHRINEACTIVE MOIETYYKH834O4BHEPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [PHYSICIANS TOTAL CARE, INC.]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBEPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [PHYSICIANS TOTAL CARE, INC.]2
Hydrochloric AcidINACTIVE INGREDIENTQTT17582CBEPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]2
NitrogenINACTIVE INGREDIENTN762921K75EPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]2
NITROGENINACTIVE INGREDIENTN762921K75EPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [PHYSICIANS TOTAL CARE, INC.]2
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XEPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [PHYSICIANS TOTAL CARE, INC.]2
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XEPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CEPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [PHYSICIANS TOTAL CARE, INC.]2
Sodium MetabisulfiteINACTIVE INGREDIENT4VON5FNS3CEPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0REPIPEN (EPINEPHRINE) INJECTION EPIPEN JR (EPINEPHRINE) INJECTION [PHYSICIANS TOTAL CARE, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0REPIPEN (EPINEPHRINE) INJECTION [DISPENSING SOLUTIONS, INC.]2

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 9 of 69 · 1,379 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
H-Focus FormulaAGNUS CASTUS, AVENA SATIVA, BARYTA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM CARBONICUM, NATRUM MURIATICUM, PHOSPHORICUM ACIDUM, SILICEA, ZINCUM METALLICUMHealing Natural Oils LLC4ee42911-3064-7f55-e063-6294a90abcc72026-04-07WarningsExact identifier
unii: 451W47IQ8X
H-Mood FormulaAGRIMONIA EUPATORIA, FLOS, ANACARDIUM ORIENTALE, AURUM METALLICUM, AVENA SATIVA, BORAGO OFFICINALIS, CAPSICUM ANNUUM, CARPINUS BETULUS, FLOS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, HYPERICUM PERFORATUM, KALI BROMATUM, LARIX DECIDUA, FLOS, NATRUM CARBONICUM, NATRUM MURIATICUM, NATRUM SULPHURICUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PULSATILLA, SILICEA, SINAPSIS ARVENSIS, FLOS, TABACUMHealing Natural Oils LLC4ee5c82e-9edf-c36e-e063-6394a90a237f2026-04-07WarningsExact identifier
unii: 451W47IQ8X
Walgreens Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEWalgreen Companybda3b9db-5fc4-408c-a5ae-d1eeb3ee308d2026-04-06WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride Ophthalmic 5 Percent Hypertonicity EyeSODIUM CHLORIDEHanlim4ee80e16-1bb1-8238-e063-6294a90aa7192026-04-04WarningsExact identifier
unii: 451W47IQ8X
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
BACTERIOSTATIC SODIUM CHLORIDESODIUM CHLORIDEHospira, Inc.376093e7-e09e-4a57-3199-195e452518662026-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Migraine and HeadacheIRIS VERSICOLOR ROOT AND SODIUM CHLORIDEForces of Nature0dd2f2e2-78e2-435e-b7b2-ca590953ff942026-04-01WarningsExact identifier
unii: 451W47IQ8X
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
Cold Sore FormulaDULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM MURIATICUM, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODENutritional Specialties, Inc.f4e7e469-baaf-4c61-af44-80b0832eadf02026-03-31WarningsExact identifier
unii: 451W47IQ8X
Sodium Chloride Normal SaltSODIUM CHLORIDETWIN MED LLC10230c8a-e5e5-44f1-b41d-80930899d6b92026-03-31WarningsExact identifier
unii: 451W47IQ8X
H-Allergy FormulaALLIUM CEPA, AMBROSIA ARTEMISIAEFOLIA, ARUM TRIPHYLLUM, ARUNDO MAURITANICA, EUPHRASIA OFFICINALIS, GALPHIMIA GLAUCA, HISTAMINUM HYDROCHLORICUM, KALI BICHROMICUM, NATRUM MURIATICUM, SOLIDAGO VIRGAUREA, STICTA PULMONARIA, SULPHUR, TRIFOLIUM PRATENSE, WYETHIA HELENIOIDESHealing Natural Oils LLC4e586360-b3c4-1ce0-e063-6394a90ab6b82026-03-31WarningsExact identifier
unii: 451W47IQ8X
Acne HPCARBO ANIMALIS, CARBO VEGETABILIS, KALI BICHROMICUM, NATRUM MURIATICUM, PULSATILLA (VULGARIS), SEPIA, SILICEA, SULPHUR, ZINCUM METALLICUMBioActive Nutritional, Inc.2ab4ff53-4274-40c7-b05c-44d918d809be2026-03-31WarningsExact identifier
unii: 451W47IQ8X
Cold Sore FormulaDULCAMARA, GLYCYRRHIZA GLABRA, RANUNCULUS BULBOSUS, RHUS TOX, NATRUM MURIATICUM, FAGOPYRUM ESCULENTUM, NATRUM HYPOCHLOROUS, ACONITUM NAPELLUS, CYTOMEGALOVIRUS NOSODE, HERPES SIMPLEX I AND II NOSODE, SEPIA, EPSTEIN BARR VIRUS NOSODE, HERPES ZOSTER NOSODE, ADENOVIREN NOSODENutritional Specialties, Inc.ad6a08ec-5eba-405b-8a07-79ac86ab3e7a2026-03-31WarningsExact identifier
unii: 451W47IQ8X
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
ANX HPARSENICUM ALBUM, CALCAREA CARBONICA, IGNATIA AMARA, KALI CARBONICUM, LACHESIS MUTUS, NATRUM MURIATICUMBioActive Nutritional, Inc.96035891-aea3-4138-bb26-801ad819f6392026-03-30WarningsExact identifier
unii: 451W47IQ8X
epinephrineEPINEPHRINEBaxter Healthcare Corporationef556382-9d19-4f0e-9dbe-fcecc772a3e22026-03-30Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Spleen LiquescenceQUERCUS ROBUR, CEANOTHUS AMERICANUS, SPLEEN (BOVINE), NATRUM MURIATICUM, HELIANTHUS ANNUUSNutritional Specialties, Inc.d800456d-60f0-413d-b310-91b8b881f6b92026-03-30WarningsExact identifier
unii: 451W47IQ8X
DepressoforcePICRICUM ACIDUM, ARSENICUM ALBUM, AURUM METALLICUM, IGNATIA AMARA, NATRUM MURIATICUM, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SEPIABioActive Nutritional, Inc.e6b98979-a38c-4f13-af03-f5ffa962b4fa2026-03-27WarningsExact identifier
unii: 451W47IQ8X
AdrenaparARALIA QUINQUEFOLIA, AVENA SATIVA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS SUIS, ARSENICUM IODATUM, CALCAREA CARBONICA, IGNATIA AMARA, LYCOPODIUM CLAVATUM, NATRUM MURIATICUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ZINCUM METALLICUMEnergique, Inc.077a9171-283d-47b6-bddc-34c739f6d69d2026-03-27WarningsExact identifier
unii: 451W47IQ8X
Buffer pHCHAMOMILLA, GRAPHITES, KALI CARBONICUM, KALI OXALICUM, KALI PHOSPHORICUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, NUX VOMICA, RHEUM (PALMATUM), ROBINIA PSEUDOACACIANaturalCare2161a2e2-613d-4dac-a5f6-796d40e849d92026-03-25WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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