FDA.reportPublic FDA data

epinephrine

Product NDC
50090-3155
11-digit product format
500903155
Labeler code
50090
Product ID
50090-3155_2a4bc2a3-d56d-4849-b134-951ee4f2b4a7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
epinephrine
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
A-S Medication Solutions
Application
NDA020800
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2010-04-01
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
epinephrine
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYKH834O4BH
Rxcui1870230

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-3155-02024-01-30C16284748780-1f386c649-c2fd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EPINEPHRINE INJECTION safely and effectively. See full prescribing information for EPINEPHRINE INJECTION. EPINEPHRINE injection, for intramuscular or subcutaneous use Initial U.S. Approval: 1939
50090-3155-02023-01-30C16284748780-1f386c649-c2fd-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use EPINEPHRINE INJECTION safely and effectively. See full prescribing information for EPINEPHRINE INJECTION. EPINEPHRINE injection, for intramuscular or subcutaneous use Initial U.S. Approval: 1939

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3155-0epinephrine2 in 1 CARTONINJECTION213
50090-3155-0epinephrine1 mL in 1 CASEINJECTION113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3155-0EA - Each50090-3155a135e227-16fc-48ea-a479-67a78759621712019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3155EPINEPHRINE INJECTION [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 2 package rows20240131_a5134e63-9a31-4573-826f-b442d069b3e6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSNa5134e63-9a31-4573-826f-b442d069b3e613
1870230NDA020800 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCDa5134e63-9a31-4573-826f-b442d069b3e613
1870230epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-InjectorSYa5134e63-9a31-4573-826f-b442d069b3e613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3155-0500903155002 CASE in 1 CARTON (50090-3155-0) / 1 mL in 1 CASE2 case2017-10-050000-00-00NoNoCurrent