FDA.reportPublic FDA data

EPIPEN

Product NDC
76420-584
11-digit product format
764200584
Labeler code
76420
Product ID
76420-584_040d1b88-235a-aa09-e063-6394a90adbad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
epinephrine
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Asclemed USA, Inc.
Application
NDA019430
Marketing category
NDA
Marketing start
1987-12-22
Substance
EPINEPHRINE
Active strength
.3 mg/.3mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EPIPEN
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE.3 mg/.3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYKH834O4BH
Rxcui727347, 1870207

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-584-02EPIPEN2 in 1 CARTONINJECTION21
76420-584-02EPIPEN1 in 1 CONTAINERINJECTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-584EPIPEN (EPINEPHRINE) INJECTION [ASCLEMED USA, INC.]1Current NDC, 2 package rows20230830_311af6d9-20c0-4b87-b236-4185bfa49988.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870207EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-InjectorPSN311af6d9-20c0-4b87-b236-4185bfa499881
727347EpiPen 0.3 MG in 0.3 ML Auto-InjectorPSN311af6d9-20c0-4b87-b236-4185bfa499881
727347NDA019430 0.3 ML epinephrine 1 MG/ML Auto-Injector [Epipen]SBD311af6d9-20c0-4b87-b236-4185bfa499881
1870207NDA019430 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCD311af6d9-20c0-4b87-b236-4185bfa499881
7273470.3 ML Epipen 1 MG/ML Auto-InjectorSY311af6d9-20c0-4b87-b236-4185bfa499881
1870207epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-InjectorSY311af6d9-20c0-4b87-b236-4185bfa499881
727347Epipen 0.3 MG per 0.3 ML Auto-InjectorSY311af6d9-20c0-4b87-b236-4185bfa499881
727347NDA019430 0.3 ML Epipen 1 MG/ML Auto-InjectorSY311af6d9-20c0-4b87-b236-4185bfa499881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-584-02764200584022 CONTAINER in 1 CARTON (76420-584-02) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS2 container2023-08-29NoNoHistorical