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 6 of 69 · 1,379 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BM BIO16CALC PHOS, FERR PHOS, KALI PHOS, MAG PHOS, NAT MUR.Total Operations Management LLC DBA:Bestmade Natural Products Micro53d2c34e-fa4d-9240-e063-6294a90a28da2026-06-09WarningsExact identifier
unii: 451W47IQ8X
BM BIO20CALC FLUOR, CALC SULF, KALI SULF, NAT MUR, NAT SULFTotal Operations Management LLC DBA:Bestmade Natural Products Micro53d48847-c0bf-1334-e063-6294a90acf7e2026-06-09WarningsExact identifier
unii: 451W47IQ8X
BM BM68ARGENTUM NIT, BARYTA CARB, DULCAMARA, GELSEMIUM, KALI BROM, NAT MUR, CAUSTICUMBM Private Limited53d52b7e-1e84-d4d3-e063-6294a90a9efc2026-06-09WarningsExact identifier
unii: 451W47IQ8X
ApizelenGERMANIUM METALLICUM, ALFALFA, ARALIA QUINQUEFOLIA, AVENA SATIVA, BETA VULGARIS, CALENDULA OFFICINALIS, CHELIDONIUM MAJUS, ECHINACEA (ANGUSTIFOLIA), NATRUM MURIATICUM, PALOONDO, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, URTICA DIOICA, VISCUM ALBUM, COBALT ACETATE, COBALT GLUCONATE, COPPER GLUCONATE, CUPRUM ACETICUM, GLUTATHIONE, MAGNESIUM GLUCONICUM DIHYDRICUM, GANODERMA LUCIDUM, UBIDECARENONUM, ARGENTUM METALLICUMBioActive Nutritional, Inc.471a7fab-1ef1-4d13-a28e-75f9762a711a2026-06-08WarningsExact identifier
unii: 451W47IQ8X
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
BM Nat MurNATRIUM MURIATICUMTotal Operations Management LLC DBA:Bestmade Natural Products Micro53baa9ce-5ce6-7bba-e063-6294a90a517a2026-06-08WarningsExact identifier
unii: 451W47IQ8X
EpinephrineEPINEPHRINEREMEDYREPACK INC.0172280c-f7d6-4613-9dbd-f94d3ae5825a2026-06-08Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
BM Nat Mur Icing SugarNATRUM MURIATICUM ICING SUGARTotal Operations Management LLC DBA:Bestmade Natural Products Micro5356d350-1325-7299-e063-6294a90a96a02026-06-03WarningsExact identifier
unii: 451W47IQ8X
NitrogenNITROGENTerry Supply Company Inc52e5a40a-e974-929e-e063-6294a90aa5772026-05-28Exact identifier
unii: N762921K75
PlegisolPOTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDEHospira, Inc.35a174f0-f0d7-4ec7-3f81-d3d572c059cf2026-05-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
TPN ElectrolytesSODIUM CHLORIDE, CALCIUM CHLORIDE, POTASSIUM CHLORIDE, MAGNESIUM CHLORIDE, AND SODIUM ACETATE ANHYDROUSHospira, Inc.c00817bc-7b62-4abe-0280-e7930eda3f942026-05-25Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
SALINE CLEANINGSODIUM CHLORIDEGuangzhou Huanmei Cosmetics Co., Ltd.524f07cc-ddb9-dda5-e063-6394a90ac0a52026-05-21WarningsExact identifier
unii: 451W47IQ8X
NitrogenNITROGENNexAir, LLC4da119c6-59e9-4f95-9c0c-483b5e2162fb2026-05-21Exact identifier
unii: N762921K75
Lidocaine Hydrochloride and EpinephrineLIDOCAINE HYDROCHLORIDE AND EPINEPHRINECardinal Health 107, LLC77fd6ee4-108f-4525-8df5-7db9236042ee2026-05-20Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
Sodium ChlorideSODIUM CHLORIDEHospira, Inc.a2a964f7-c3ec-4dfb-e3a0-6d8136a803972026-05-19Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Muriaticum acidumHYDROCHLORIC ACIDBoiron8643bc58-bb0e-5c79-e053-2991aa0a02ae2026-05-19WarningsExact identifier
unii: QTT17582CB
HerplexANATHERUM MURICATUM, CLEMATIS ERECTA, MEZEREUM, PHYTOLACCA DECANDRA, RANUNCULUS BULBOSUS, RHUS TOX, THUJA OCCIDENTALIS, NATRUM MURIATICUM, SEPIANashco Products LLCe5e7aa2f-3697-4747-9045-670ea2b135572026-05-14WarningsExact identifier
unii: 451W47IQ8X
NebuClear MDSALINEBlue Echo Care LLC3f85fe62-230f-b0f1-e063-6394a90a5cb82026-05-11WarningsExact identifier
unii: 451W47IQ8X

Reported adverse events (FAERS/openFDA)#

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