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 4 of 69 · 1,379 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SALINE NASALSODIUM CHLORIDEALAINA HEALTHCARE PRIVATE LIMITEDed30a7f9-7132-42da-9bed-63a9b1c80ab22026-07-07WarningsExact identifier
unii: 451W47IQ8X
EpinephrineEPINEPHRINEA-S Medication Solutions386519ba-7a44-4edd-9eb1-748419b7a71b2026-07-06Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
AdrenalinEPINEPHRINEPar Health USA, LLC3b7a4364-668d-4eb2-a20c-04adc35aabe42026-07-01Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
The Cell Salt Co. Daily Blend 12 in 1CALC FLUOR, CALC PHOS, CALC SULPH, FERRUM PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT MUR, NAT PHOS, NAT SULPH, SILICEAThe Cell Salt Company LLC55826f59-acf4-7370-e063-6394a90afed72026-07-01WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55820ff9-7b4b-2bce-e063-6394a90a8b432026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC55806cb8-cf92-c4e5-e063-6394a90aaa2d2026-06-30WarningsExact identifier
unii: 451W47IQ8X
NebuClear MD SalineNEBUCLEAR MD SALINEBlue Echo Care LLC5581d8e5-4105-e9da-e063-6394a90a316e2026-06-30WarningsExact identifier
unii: 451W47IQ8X
LIDOCAINE HCILIDOCAINE HCIHF Acquisition Co LLC, DBA HealthFirst76176d50-a987-c9f9-e053-2991aa0aea0f2026-06-29Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
unii: 059QF0KO0R
MCAS SupportAPIS MELLIFICA, ANTIMONIUM CRUDUM, ASCORBICUM ACIDUM, BOVISTA, CARBOLICUM ACIDUM, CHAMOMILLA, CORTISONE ACETICUM, GINKGO BILOBA, HEPAR SUIS, HISTAMINUM HYDROCHLORICUM, NATRUM MURIATICUM, QUERCETIN, RHUS TOX, SCUTELLARIA LATERIFLORA, STOMACH (SUIS), URTICA URENSDeseret Biologicals, Inc.af3d5f8f-6f24-4045-8730-c776ff54bcc42026-06-24WarningsExact identifier
unii: 451W47IQ8X
Bacteriostatic WaterBACTERIOSTATIC WATERFujian Genohope Biotech Ltd.54f66b82-c9e5-a2bc-e063-6394a90adbbc2026-06-23Exact identifier
unii: 059QF0KO0R
LIDOCAINE HCl AND EPINEPHRINELIDOCAINE HCL AND EPINEPHRINEHF Acquisition Co LLC, DBA HealthFirsta09613b2-4337-5b52-e053-2995a90ab74b2026-06-19Warnings, Adverse reactionsExact identifier
unii: YKH834O4BH
NitrogenNITROGENMaine Oxy-Acetylene Supply Company652ecc66-c6bb-40a3-a12f-64c7a4cdaca82026-06-18Exact identifier
unii: N762921K75

Reported adverse events (FAERS/openFDA)#

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