FDA.reportPublic FDA data

epinephrine

Product NDC
68083-633
11-digit product format
680830633
Labeler code
68083
Product ID
68083-633_a7f9fba5-54b0-4001-ba9b-86468e159db7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
epinephrine
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Gland Pharma Limited
Application
ANDA219239
Marketing category
ANDA
Marketing start
2025-02-06
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68083-633-01epinephrine1 in 1 CARTONINJECTION15
68083-633-01epinephrine10 mL in 1 VIAL, MULTI-DOSEINJECTION105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68083-633EPINEPHRINE INJECTION [GLAND PHARMA LIMITED]3Current NDC, 2 package rows20250213_79ca73ca-d3c0-40af-9dec-e2f4ce669cda.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310132EPINEPHrine 1 MG/ML (1:1000) Injectable SolutionPSN79ca73ca-d3c0-40af-9dec-e2f4ce669cda5
310132epinephrine 1 MG/ML Injectable SolutionSCD79ca73ca-d3c0-40af-9dec-e2f4ce669cda5
310132epinephrine (as epinephrine hydrochloride) 1 MG/ML Injectable SolutionSY79ca73ca-d3c0-40af-9dec-e2f4ce669cda5
310132epinephrine 1:1000 Injectable SolutionSY79ca73ca-d3c0-40af-9dec-e2f4ce669cda5
310132epinephrine 500 MCG per 0.5 ML Injectable SolutionSY79ca73ca-d3c0-40af-9dec-e2f4ce669cda5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68083-633-01680830633011 VIAL, MULTI-DOSE in 1 CARTON (68083-633-01) / 10 mL in 1 VIAL, MULTI-DOSE2025-02-06NoNoCurrent