FDA.reportPublic FDA data

epinephrine

Product NDC
70518-2048
11-digit product format
705182048
Labeler code
70518
Product ID
70518-2048_4dc53fa6-22ad-c2f5-e063-6394a90a526a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
epinephrine
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
REMEDYREPACK INC.
Application
NDA020800
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-04-29
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
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYKH834O4BH
Rxcui1870230

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
70518-2048-0epinephrine1 in 1 CASEINJECTION113
70518-2048-0epinephrine2 in 1 CARTONINJECTION213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2048-0EA - Each70518-204815f2b7ca-2c6e-4f2c-943c-8c683406a1bf12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2048EPINEPHRINE INJECTION [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 2 package rows20250306_c66de0d3-3b0f-4e52-a712-60357a107676.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870230EPINEPHrine (generic for Adrenaclick) 0.3 MG in 0.3 ML Auto-InjectorPSNc66de0d3-3b0f-4e52-a712-60357a10767613
1870230NDA020800 0.3 ML epinephrine 1 MG/ML Auto-InjectorSCDc66de0d3-3b0f-4e52-a712-60357a10767613
1870230epinephrine (generic for Adrenaclick) 0.3 MG per 0.3 ML Auto-InjectorSYc66de0d3-3b0f-4e52-a712-60357a10767613

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2048-0705182048002 CASE in 1 CARTON (70518-2048-0) / 1 SYRINGE, GLASS in 1 CASE / .3 mL in 1 SYRINGE, GLASS2 case2019-04-290000-00-00NoNoCurrent