FDA.reportPublic FDA data

epinephrine

Product NDC
43066-801
11-digit product format
430660801
Labeler code
43066
Product ID
43066-801_ef556382-9d19-4f0e-9dbe-fcecc772a3e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
epinephrine
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Baxter Healthcare Corporation
Application
NDA220626
Marketing category
NDA
Marketing start
2026-03-30
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
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
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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43066-801-01epinephrine30 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION, CONCENTRATE301
43066-801-02epinephrine1 in 1 CARTONINJECTION, SOLUTION, CONCENTRATE11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43066-801-01ML - Milliliter43066-801bc3393d9-e279-4d2e-9640-ef432e5abd7512026-05-22
43066-801-02ML - Milliliter43066-801e0b80998-fc53-4c33-a55f-194d41a180b312026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1660014EPINEPHrine 1 MG in 1 ML InjectionPSNef556382-9d19-4f0e-9dbe-fcecc772a3e21
310132EPINEPHrine 1 MG/ML (1:1000) Injectable SolutionPSNef556382-9d19-4f0e-9dbe-fcecc772a3e21
16600141 ML epinephrine 1 MG/ML InjectionSCDef556382-9d19-4f0e-9dbe-fcecc772a3e21
310132epinephrine 1 MG/ML Injectable SolutionSCDef556382-9d19-4f0e-9dbe-fcecc772a3e21
310132epinephrine (as epinephrine hydrochloride) 1 MG/ML Injectable SolutionSYef556382-9d19-4f0e-9dbe-fcecc772a3e21
1660014epinephrine 1 MG per 1 ML InjectionSYef556382-9d19-4f0e-9dbe-fcecc772a3e21
310132epinephrine 1:1000 Injectable SolutionSYef556382-9d19-4f0e-9dbe-fcecc772a3e21
310132epinephrine 500 MCG per 0.5 ML Injectable SolutionSYef556382-9d19-4f0e-9dbe-fcecc772a3e21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43066-801-014306608010130 mL in 1 VIAL, MULTI-DOSE30 mlHistorical
43066-801-02430660801021 VIAL, MULTI-DOSE in 1 CARTON (43066-801-02) / 30 mL in 1 VIAL, MULTI-DOSE (43066-801-01) 2026-03-30NoNoHistorical