EPINEPHRINE

Product NDC
54288-117
11-digit product format
542880117
Labeler code
54288
Product ID
54288-117_7247d0b3-45ab-4da1-bf25-61e31a0960ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EPINEPHRINE
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
BPI Labs, LLC
Application
NDA205029
Marketing category
NDA
Marketing start
2023-05-24
Substance
EPINEPHRINE
Active strength
1 mg/mL
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
EPINEPHRINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYKH834O4BH
Rxcui2637533

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
54288-117-01EPINEPHRINE1 mL in 1 SYRINGE, GLASSINJECTION17
54288-117-10EPINEPHRINE10 in 1 CARTONINJECTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-117EPINEPHRINE INJECTION [BPI LABS, LLC]5Current NDC, 2 package rows20250321_7499cbca-b8fe-4fc3-a318-13859ab989a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2637533EPINEPHrine 1 MG in 1 ML Prefilled SyringePSN7499cbca-b8fe-4fc3-a318-13859ab989a77
26375331 ML epinephrine 1 MG/ML Prefilled SyringeSCD7499cbca-b8fe-4fc3-a318-13859ab989a77
2637533epinephrine 1 MG per 1 ML Prefilled SyringeSY7499cbca-b8fe-4fc3-a318-13859ab989a77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54288-117-01542880117011 mL in 1 SYRINGE, GLASS1 mlHistorical
54288-117-105428801171010 SYRINGE, GLASS in 1 CARTON (54288-117-10) / 1 mL in 1 SYRINGE, GLASS (54288-117-01) 2023-05-24NoNoCurrent