FDA.reportPublic FDA data

epinephrine

Product NDC
0338-0024
11-digit product format
003380024
Labeler code
0338
Product ID
0338-0024_74cb9596-3ecd-4d54-8a27-9dc270938aac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
epinephrine
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Baxter Healthcare Corporation
Application
NDA218475
Marketing category
NDA
Marketing start
2025-02-28
Substance
EPINEPHRINE BITARTRATE
Active strength
64 ug/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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
epinephrine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE BITARTRATE64 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii30Q7KI53AK
Rxcui2695029, 2707568

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
0338-0024-20epinephrine20 in 1 CARTONINJECTION, SOLUTION209
0338-0024-20epinephrine250 mL in 1 BAGINJECTION, SOLUTION2509

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0338-0024EPINEPHRINE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]5Current NDC, 2 package rows20250507_60efd409-3555-4182-a68d-1cd7bc0d1bfc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2695029EPINEPHrine 4 MG in 250 ML InjectionPSN60efd409-3555-4182-a68d-1cd7bc0d1bfc9
2707568EPINEPHrine bitartrate 16 MG in 250 ML InjectionPSN60efd409-3555-4182-a68d-1cd7bc0d1bfc9
2695029250 ML epinephrine 0.016 MG/ML InjectionSCD60efd409-3555-4182-a68d-1cd7bc0d1bfc9
2707568250 ML epinephrine 0.064 MG/ML InjectionSCD60efd409-3555-4182-a68d-1cd7bc0d1bfc9
2707568epinephrine (as bitartrate) 16 MG per 250 ML InjectionSY60efd409-3555-4182-a68d-1cd7bc0d1bfc9
2695029epinephrine 4 MG per 250 ML InjectionSY60efd409-3555-4182-a68d-1cd7bc0d1bfc9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0338-0024-200033800242020 BAG in 1 CARTON (0338-0024-20) / 250 mL in 1 BAG20 bag2025-02-28NoNoCurrent