FDA.reportPublic FDA data

Epinephrine

Product NDC
63629-8801
11-digit product format
636298801
Labeler code
63629
Product ID
63629-8801_b14f5646-83b8-423b-b1d2-df06b1169be2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Epinephrine
Dosage form
INJECTION
Route
INTRAMUSCULAR; SUBCUTANEOUS
Labeler
Bryant Ranch Prepack
Application
ANDA090589
Marketing category
ANDA
Marketing start
2019-08-19
Substance
EPINEPHRINE
Active strength
.15 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.15 mg/.3mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYKH834O4BH
Rxcui727316

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
63629-8801-1Epinephrine2 in 1 CARTONINJECTION2103
63629-8801-1Epinephrine1 in 1 CONTAINERINJECTION1103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8801-1EA - Each63629-8801ad99a62b-7ded-45c4-99e3-b341698c264012021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8801EPINEPHRINE INJECTION [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 2 package rows20240116_a7ae17f8-de81-4de9-a89f-bb930c6a27ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
727316EPINEPHrine (generic for EpiPen Jr) 0.15 MG in 0.3 ML Auto-InjectorPSNa7ae17f8-de81-4de9-a89f-bb930c6a27ec103
727316NDA019430 0.3 ML epinephrine 0.5 MG/ML Auto-InjectorSCDa7ae17f8-de81-4de9-a89f-bb930c6a27ec103
727316epinephrine (generic for EpiPen Jr) 0.15 MG per 0.3 ML Auto-InjectorSYa7ae17f8-de81-4de9-a89f-bb930c6a27ec103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8801-1636298801012 CONTAINER in 1 CARTON (63629-8801-1) / 1 SYRINGE in 1 CONTAINER / .3 mL in 1 SYRINGE2 container2021-09-100000-00-00NoNoCurrent