FDA.reportPublic FDA data

Epinephrine

Product NDC
49502-102
11-digit product format
495020102
Labeler code
49502
Product ID
49502-102_b526b53a-fe41-462e-b453-745f36d136eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Epinephrine
Dosage form
INJECTION
Route
INTRAMUSCULAR
Labeler
Viatris Specialty LLC
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
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
EPINEPHRINE.3 mg/.3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYKH834O4BH
Rxcui727316, 1870207

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
49502-102-01Epinephrine0.3 mL in 1 SYRINGE, GLASSINJECTION0.335
49502-102-01Epinephrine1 in 1 CONTAINERINJECTION135
49502-102-02Epinephrine2 in 1 CARTONINJECTION235

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49502-102EPINEPHRINE INJECTION [VIATRIS SPECIALTY LLC]35Current NDC, Legacy NDC, 3 package rows20250215_778ac6ae-6bcb-47a4-bcb3-8dd0da9f8836.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
727316EPINEPHrine (generic for EpiPen Jr) 0.15 MG in 0.3 ML Auto-InjectorPSN778ac6ae-6bcb-47a4-bcb3-8dd0da9f883635
1870207EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-InjectorPSN778ac6ae-6bcb-47a4-bcb3-8dd0da9f883635
727316NDA019430 0.3 ML epinephrine 0.5 MG/ML Auto-InjectorSCD778ac6ae-6bcb-47a4-bcb3-8dd0da9f883635
1870207NDA019430 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCD778ac6ae-6bcb-47a4-bcb3-8dd0da9f883635
727316epinephrine (generic for EpiPen Jr) 0.15 MG per 0.3 ML Auto-InjectorSY778ac6ae-6bcb-47a4-bcb3-8dd0da9f883635
1870207epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-InjectorSY778ac6ae-6bcb-47a4-bcb3-8dd0da9f883635
1870207EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-InjectorPSNb7a4171c-7934-4723-a140-bd93ea84aae17
1870207NDA019430 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCDb7a4171c-7934-4723-a140-bd93ea84aae17
1870207epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-InjectorSYb7a4171c-7934-4723-a140-bd93ea84aae17
1870207EPINEPHrine (generic for EpiPen) 0.3 MG in 0.3 ML Auto-InjectorPSN6bce7d5c-bb6b-1f36-e053-2a91aa0a68ab4
1870207NDA019430 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCD6bce7d5c-bb6b-1f36-e053-2a91aa0a68ab4
1870207epinephrine (generic for EpiPen) 0.3 MG per 0.3 ML Auto-InjectorSY6bce7d5c-bb6b-1f36-e053-2a91aa0a68ab4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49502-102-01495020102010.3 mL in 1 SYRINGE, GLASS0.3 mlHistorical
49502-102-02495020102022 CONTAINER in 1 CARTON (49502-102-02) / 1 SYRINGE, GLASS in 1 CONTAINER (49502-102-01) / .3 mL in 1 SYRINGE, GLASS2 container2016-12-150000-00-00NoNoCurrent