FDA.reportPublic FDA data

Epinephrine 0.3 Adults

Product NDC
70385-2019
11-digit product format
703852019
Labeler code
70385
Product ID
70385-2019_48356139-781a-c76a-e063-6394a90a5e80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Epinephrine 0.3 Adults
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Sina Health Inc
Application
NDA019430
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2016-12-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Epinephrine 0.3 Adults
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYKH834O4BH
Rxcui1870207

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
70385-2019-1Epinephrine 0.3 Adults1 in 1 PACKAGEINJECTION136
70385-2019-1Epinephrine 0.3 Adults1 in 1 CONTAINERINJECTION136

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70385-2019EPINEPHRINE 0.3 ADULTS INJECTION [SINA HEALTH INC]35Current NDC, 2 package rows20241207_2865e9a5-1228-e2bc-e063-6394a90af94e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870207EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-InjectorPSN2865e9a5-1228-e2bc-e063-6394a90af94e36
1870207NDA019430 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCD2865e9a5-1228-e2bc-e063-6394a90af94e36
1870207epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-InjectorSY2865e9a5-1228-e2bc-e063-6394a90af94e36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70385-2019-1703852019011 CONTAINER in 1 PACKAGE (70385-2019-1) / 1 SYRINGE, GLASS in 1 CONTAINER / .3 mL in 1 SYRINGE, GLASS1 container2016-12-15NoNoHistorical