epinephrine

Product NDC
0517-1171
11-digit product format
005171171
Labeler code
0517
Product ID
0517-1171_ca2af610-a1fe-420d-812c-d1ae3d07d6fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
epinephrine
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
American Regent, Inc.
Application
ANDA207568
Marketing category
ANDA
Marketing start
2023-01-31
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
0517-1171-01epinephrine1 mL in 1 AMPULEINJECTION, SOLUTION14
0517-1171-10epinephrine10 in 1 BOXINJECTION, SOLUTION104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0517-1171-01ML - Milliliter0517-117112899cb1-9d94-4b8c-b0c5-3996e74ed49d12023-02-06
0517-1171-10ML - Milliliter0517-11712d07635b-64ed-4230-9732-f584b77392ae12023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0517-1171EPINEPHRINE INJECTION, SOLUTION [AMERICAN REGENT, INC.]4Current NDC, Legacy NDC, 2 package rows20240517_6add7604-71f6-4d8a-9447-17ad01fa839d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1660014EPINEPHrine 1 MG in 1 ML InjectionPSN6add7604-71f6-4d8a-9447-17ad01fa839d4
16600141 ML epinephrine 1 MG/ML InjectionSCD6add7604-71f6-4d8a-9447-17ad01fa839d4
1660014epinephrine 1 MG per 1 ML InjectionSY6add7604-71f6-4d8a-9447-17ad01fa839d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0517-1171-01005171171011 mL in 1 AMPULE1 mlHistorical
0517-1171-100051711711010 AMPULE in 1 BOX (0517-1171-10) / 1 mL in 1 AMPULE (0517-1171-01) 10 ampule2023-01-310000-00-00NoNoCurrent