FDA.reportPublic FDA data

Epinephrine

Product NDC
50090-3039
11-digit product format
500903039
Labeler code
50090
Product ID
50090-3039_f5379d23-2409-4aec-8ccb-0ee72a3f56a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Epinephrine
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAMUSCULAR; INTRAOCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
NDA205029
Marketing category
NDA
Marketing start
2014-08-08
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
Rxcui1660014

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
50090-3039-0Epinephrine1 mL in 1 AMPULEINJECTION, SOLUTION, CONCENTRATE113
50090-3039-0Epinephrine25 in 1 BOXINJECTION, SOLUTION, CONCENTRATE2513
50090-3039-1Epinephrine1 mL in 1 AMPULEINJECTION, SOLUTION, CONCENTRATE113
50090-3039-2Epinephrine1 mL in 1 AMPULEINJECTION, SOLUTION, CONCENTRATE113
50090-3039-2Epinephrine10 in 1 BOXINJECTION, SOLUTION, CONCENTRATE1013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3039-1ML - Milliliter50090-30394eb35a65-c15f-43fb-97f6-d6d632b84e7d12022-02-07
50090-3039-2ML - Milliliter50090-3039b20f211a-2d6b-4573-b0fb-df975054106c12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3039EPINEPHRINE INJECTION, SOLUTION, CONCENTRATE [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 5 package rows20250115_386519ba-7a44-4edd-9eb1-748419b7a71b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1660014EPINEPHrine 1 MG in 1 ML InjectionPSN386519ba-7a44-4edd-9eb1-748419b7a71b13
16600141 ML epinephrine 1 MG/ML InjectionSCD386519ba-7a44-4edd-9eb1-748419b7a71b13
1660014epinephrine 1 MG per 1 ML InjectionSY386519ba-7a44-4edd-9eb1-748419b7a71b13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3039-05009030390025 AMPULE in 1 BOX (50090-3039-0) > 1 mL in 1 AMPULE25 ampule2019-10-090000-00-00NoNoCurrent
50090-3039-1500903039011 mL in 1 AMPULE (50090-3039-1) 1 ml2017-06-060000-00-00NoNoCurrent
50090-3039-25009030390210 AMPULE in 1 BOX (50090-3039-2) > 1 mL in 1 AMPULE10 ampule2018-03-260000-00-00NoNoCurrent