FDA.reportPublic FDA data

EPINEPHRINE

Product NDC
54288-600
11-digit product format
542880600
Labeler code
54288
Product ID
54288-600_79bfbdaf-2a2d-4b68-8f10-3daf37fdc423
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
EPINEPHRINE
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
BPI Labs, LLC
Application
NDA205029
Marketing category
NDA
Marketing start
2023-01-16
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
Rxcui310132

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
54288-600-012025-02-11C16284748780-12cef2736-7b90-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use EPINEPHRINE INJECTION USP safely and effectively. See full prescribing information for EPINEPHRINE INJECTION USP. EPINEPHRINE INJECTION, USP for intravenous, intramuscular, subcutaneous use Initial U.S. Approval: 1939
54288-600-012025-02-11C16284748780-12cef2736-7b90-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use EPINEPHRINE INJECTION USP safely and effectively. See full prescribing information for EPINEPHRINE INJECTION USP. EPINEPHRINE INJECTION, USP for intravenous, intramuscular, subcutaneous use Initial U.S. Approval: 1939
54288-600-012025-02-11C16284748780-12cef2736-7b90-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use EPINEPHRINE INJECTION USP safely and effectively. See full prescribing information for EPINEPHRINE INJECTION USP. EPINEPHRINE INJECTION, USP 10 mg/10 mL (1 mg/mL) Multiple Dose Vial, for intravenous, intramuscular, subcutaneous use Initial U.S. Approval: 1939
54288-600-012025-01-30C16284748780-12cef2736-7b90-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use EPINEPHRINE INJECTION USP safely and effectively. See full prescribing information for EPINEPHRINE INJECTION USP. EPINEPHRINE INJECTION, USP for intravenous, intramuscular, subcutaneous use Initial U.S. Approval: 1939
54288-600-012025-01-30C16284748780-12cef2736-7b90-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use EPINEPHRINE INJECTION USP safely and effectively. See full prescribing information for EPINEPHRINE INJECTION USP. EPINEPHRINE INJECTION, USP for intravenous, intramuscular, subcutaneous use Initial U.S. Approval: 1939
54288-600-012025-01-30C16284748780-12cef2736-7b90-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use EPINEPHRINE INJECTION USP safely and effectively. See full prescribing information for EPINEPHRINE INJECTION USP. EPINEPHRINE INJECTION, USP 10 mg/10 mL (1 mg/mL) Multiple Dose Vial, for intravenous, intramuscular, subcutaneous use Initial U.S. Approval: 1939

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54288-600-01EPINEPHRINE10 mL in 1 VIALINJECTION105
54288-600-01EPINEPHRINE1 in 1 CARTONINJECTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-600EPINEPHRINE INJECTION [BPI LABS, LLC]3Current NDC, 2 package rows20250213_3fd8dd51-0aeb-43dd-9de0-c11b0330b15e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310132EPINEPHrine 1 MG/ML (1:1000) Injectable SolutionPSN3fd8dd51-0aeb-43dd-9de0-c11b0330b15e5
310132epinephrine 1 MG/ML Injectable SolutionSCD3fd8dd51-0aeb-43dd-9de0-c11b0330b15e5
310132epinephrine (as epinephrine hydrochloride) 1 MG/ML Injectable SolutionSY3fd8dd51-0aeb-43dd-9de0-c11b0330b15e5
310132epinephrine 1:1000 Injectable SolutionSY3fd8dd51-0aeb-43dd-9de0-c11b0330b15e5
310132epinephrine 500 MCG per 0.5 ML Injectable SolutionSY3fd8dd51-0aeb-43dd-9de0-c11b0330b15e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54288-600-01542880600011 VIAL in 1 CARTON (54288-600-01) / 10 mL in 1 VIAL1 vial2023-01-16NoNoCurrent