EPINEPHRINE

Product NDC
54288-119
11-digit product format
542880119
Labeler code
54288
Product ID
54288-119_cb28673a-ca0d-498d-94c4-cc2f34c3108b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EPINEPHRINE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
BPI Labs, LLC
Application
NDA205029
Marketing category
NDA
Marketing start
2024-03-07
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
Rxcui310132, 1660014

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-119EPINEPHRINE INJECTION [BPI LABS, LLC]8Current NDC20250321_db18519b-82a9-435b-85c7-a040d644f057.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1660014EPINEPHrine 1 MG in 1 ML InjectionPSNdb18519b-82a9-435b-85c7-a040d644f05711
310132EPINEPHrine 1 MG/ML (1:1000) Injectable SolutionPSNdb18519b-82a9-435b-85c7-a040d644f05711
16600141 ML epinephrine 1 MG/ML InjectionSCDdb18519b-82a9-435b-85c7-a040d644f05711
310132epinephrine 1 MG/ML Injectable SolutionSCDdb18519b-82a9-435b-85c7-a040d644f05711
310132epinephrine (as epinephrine hydrochloride) 1 MG/ML Injectable SolutionSYdb18519b-82a9-435b-85c7-a040d644f05711
1660014epinephrine 1 MG per 1 ML InjectionSYdb18519b-82a9-435b-85c7-a040d644f05711
310132epinephrine 1:1000 Injectable SolutionSYdb18519b-82a9-435b-85c7-a040d644f05711
310132epinephrine 500 MCG per 0.5 ML Injectable SolutionSYdb18519b-82a9-435b-85c7-a040d644f05711
1660014EPINEPHrine 1 MG in 1 ML InjectionPSN5ba14408-c8fb-4734-aad9-ee19696acac24
16600141 ML epinephrine 1 MG/ML InjectionSCD5ba14408-c8fb-4734-aad9-ee19696acac24
1660014epinephrine 1 MG per 1 ML InjectionSY5ba14408-c8fb-4734-aad9-ee19696acac24
1660014EPINEPHrine 1 MG in 1 ML InjectionPSN409581e7-ab70-41f3-e063-6294a90a15dc1
16600141 ML epinephrine 1 MG/ML InjectionSCD409581e7-ab70-41f3-e063-6294a90a15dc1
1660014epinephrine 1 MG per 1 ML InjectionSY409581e7-ab70-41f3-e063-6294a90a15dc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54288-119-105428801191010 VIAL in 1 CARTON (54288-119-10) / 1 mL in 1 VIAL10 vial2024-03-07NoNoCurrent
54288-119-255428801192525 VIAL in 1 CARTON (54288-119-25) / 1 mL in 1 VIAL25 vial2024-03-07NoNoCurrent