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 3 of 69 · 1,379 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MetabatoneARALIA RACEMOSA, AVENA SATIVA, BERBERIS VULGARIS, CAPSICUM ANNUUM, GINKGO BILOBA, PHYTOLACCA DECANDRA, HYPOTHALAMUS SUIS, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-KETOGLUTARICUM ACIDUM, FEL TAURI, HYALURONIDASE, PANCREAS SUIS, PANCREATINUM, PAPAIN, STOMACH (SUIS), L-ALANINE, L- ARGININE, L-CARNITINE, CYSTEINUM, L-GLUTAMINE, L-HISTIDINE, L-ISOLEUCINE, L-LEUCINE, L-LYSINE, L-METHIONINE, L-ORNITHINE, L-PROLINE, L-SERINE, L-TRYPTOPHAN, L-TYROSINE, L-VALINE, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, IODIUM,Energique, Inc.9510bb76-b717-407d-b9e8-da7743e4cfc82026-07-31WarningsExact identifier
unii: 451W47IQ8X
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic SalineSODIUM CHLORIDENAVEH PHARMA (1996) LTD167c7a9c-1228-4fb2-a89c-d3e1483863232026-07-30WarningsExact identifier
unii: 451W47IQ8X
Hypertonic Saline Solution Sodium ChlorideSODIUM CHLORIDENAVEH PHARMA (1996) LTD750ea4b1-de2b-4299-aaa2-331daf383d0d2026-07-30WarningsExact identifier
unii: 451W47IQ8X
EPINEPHRINEEPINEPHRINEFresenius Kabi USA, LLCa6afb9e8-1db9-480c-8d31-58c5c870ca492026-07-29Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
DelflexDEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.a98facd6-9daa-4d37-8209-63a0599dbfaa2026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care de Mexico, S.A. de C.V.9a1220fb-6853-45ae-838c-10d8596e1af72026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sodium ChlorideSODIUM CHLORIDEFresenius Medical Care Renal Therapies Group, LLCaf5cdf1a-19f4-11e2-892e-0800200c9a662026-07-27Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Whisidom Saline SolutionSODIUM CHLORIDE 0.9% SALINE SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4e4e4169-2a14-3466-e063-6394a90a081b2026-07-20WarningsExact identifier
unii: 451W47IQ8X
SalineNASALBEST CHOICE (VALU MERCHANDISERS COMPANY)71485e82-bf54-4b8b-8dd2-2a07615345202026-07-17WarningsExact identifier
unii: 451W47IQ8X
NitrogenNITROGENLinde Inc.11f1ea16-93eb-4994-ba96-d0d7519015e22026-07-16Exact identifier
unii: N762921K75
Sodium ChlorideSODIUM CHLORIDELABORATORIOS GRIFOLS SAeb811d79-fdb8-1f1a-c2ad-1cc4bfc7eadf2026-07-15Warnings, Adverse reactionsExact identifier
unii: 451W47IQ8X
EPINEPHRINEEPINEPHRINEFresenius Kabi USA, LLC4f83895f-638c-4515-af03-7c41ae60a42e2026-07-15Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
EpinephrineEPINEPHRINEA-S Medication Solutions6e811e28-0199-4df7-a916-5940c632401d2026-07-13Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
WHWSWB 0.9% SALINESODIUM CHLORIDEYiwu Huanshu E-commerce Co., Ltd5082b773-79b2-2501-e063-6394a90a170f2026-07-11WarningsExact identifier
unii: 451W47IQ8X
EPINEPHRINEEPINEPHRINECIVICA, INC.4a79ad00-405b-4454-a692-7f1daac4adec2026-07-10Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH

Reported adverse events (FAERS/openFDA)#

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