FDA.reportPublic FDA data

Epinephrine Pediatrics

Product NDC
70385-2038
11-digit product format
703852038
Labeler code
70385
Product ID
70385-2038_48354e20-6d6a-9faf-e063-6394a90ac1f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Epinephrine 0.15 Pediatrics
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Sina Health Inc
Application
NDA020800
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2010-04-01
Substance
EPINEPHRINE
Active strength
.15 mg/.15mL
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 Pediatrics
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE.15 mg/.15mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYKH834O4BH
Rxcui1870225

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
70385-2038-1Epinephrine Pediatrics1 in 1 CASEINJECTION115
70385-2038-1Epinephrine Pediatrics1 in 1 PACKAGEINJECTION115

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70385-2038EPINEPHRINE PEDIATRICS (EPINEPHRINE 0.15 PEDIATRICS) INJECTION [SINA HEALTH INC]14Current NDC, 2 package rows20241207_287930f8-c5c6-56bd-e063-6394a90ad32e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1870225EPINEPHrine (generic for Adrenaclick) 0.15 MG in 0.15 ML Auto-InjectorPSN287930f8-c5c6-56bd-e063-6394a90ad32e15
1870225NDA020800 0.15 ML epinephrine 1 MG/ML Auto-InjectorSCD287930f8-c5c6-56bd-e063-6394a90ad32e15
1870225epinephrine (generic for Adrenaclick) 0.15 MG per 0.15 ML Auto-InjectorSY287930f8-c5c6-56bd-e063-6394a90ad32e15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70385-2038-1703852038011 CASE in 1 PACKAGE (70385-2038-1) / 1 SYRINGE, GLASS in 1 CASE / .15 mL in 1 SYRINGE, GLASS1 case2010-04-01NoNoHistorical