FDA.reportPublic FDA data

Adrenalin (epinephrine in sodium chloride)

Product NDC
42023-315
11-digit product format
420230315
Labeler code
42023
Product ID
42023-315_6d6942ec-d208-4ea6-9ad4-ef4b29aca966
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Epinephrine in Sodium Chloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Par Health USA, LLC
Application
NDA215875
Marketing category
NDA
Marketing start
2024-10-04
Substance
EPINEPHRINE
Active strength
16 ug/mL
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
Adrenalin (epinephrine in sodium chloride)
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE16 ug/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYKH834O4BH
Rxcui2695029, 2695032, 2707356, 2707359, 2713737, 2713740, 2719203, 2719204, 2719206, 2719209

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
42023-315-01Adrenalin (epinephrine in sodium chloride)250 mL in 1 BAGINJECTION25028
42023-315-10Adrenalin (epinephrine in sodium chloride)10 in 1 CARTONINJECTION1028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-315-01ML - Milliliter42023-315e4d307e0-8398-48f3-b26e-c4f4ba8debd712024-10-04
42023-315-10ML - Milliliter42023-315d39a5293-f4a9-4f89-8b4a-b8c52feb6f2e12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-315ADRENALIN (EPINEPHRINE IN SODIUM CHLORIDE) (EPINEPHRINE IN SODIUM CHLORIDE) INJECTION [ENDO USA, INC.]20Current NDC, 2 package rows20250522_61b0e2a2-71ed-43d6-b1a7-36d2dae651b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2719204Adrenalin 10 MG in 250 ML InjectionPSN61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2719209Adrenalin 2 MG in 250 ML InjectionPSN61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2695032Adrenalin 4 MG in 250 ML InjectionPSN61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2713740Adrenalin 5 MG in 250 ML InjectionPSN61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2707359Adrenalin 8 MG in 250 ML InjectionPSN61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2719203EPINEPHrine 10 MG in 250 ML InjectionPSN61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2719206EPINEPHrine 2 MG in 250 ML InjectionPSN61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2695029EPINEPHrine 4 MG in 250 ML InjectionPSN61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2713737EPINEPHrine 5 MG in 250 ML InjectionPSN61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2707356EPINEPHrine 8 MG in 250 ML InjectionPSN61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2719209250 ML epinephrine 0.008 MG/ML Injection [Adrenalin]SBD61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2695032250 ML epinephrine 0.016 MG/ML Injection [Adrenalin]SBD61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2713740250 ML epinephrine 0.02 MG/ML Injection [Adrenalin]SBD61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2707359250 ML epinephrine 0.032 MG/ML Injection [Adrenalin]SBD61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2719204250 ML epinephrine 0.04 MG/ML Injection [Adrenalin]SBD61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2719206250 ML epinephrine 0.008 MG/ML InjectionSCD61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2695029250 ML epinephrine 0.016 MG/ML InjectionSCD61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2713737250 ML epinephrine 0.02 MG/ML InjectionSCD61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2707356250 ML epinephrine 0.032 MG/ML InjectionSCD61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2719203250 ML epinephrine 0.04 MG/ML InjectionSCD61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2695032250 ML Adrenalin 0.016 MG/ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2719204Adrenalin 10 MG per 250 ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2719209Adrenalin 2 MG per 250 ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2713740Adrenalin 20 MCG/ML per 250 ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2707359Adrenalin 32 MCG/ML per 250 ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2695032Adrenalin 4 MG per 250 ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2719204Adrenalin 40 MCG/ML per 250 ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2713740Adrenalin 5 MG per 250 ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2719209Adrenalin 8 MCG/ML per 250 ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2707359Adrenalin 8 MG per 250 ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2719203epinephrine 10 MG per 250 ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2719206epinephrine 2 MG per 250 ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2713737epinephrine 20 MCG/ML per 250 ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2707356epinephrine 32 MCG/ML per 250 ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2695029epinephrine 4 MG per 250 ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2719203epinephrine 40 MCG/ML per 250 ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2713737epinephrine 5 MG per 250 ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2719206epinephrine 8 MCG/ML per 250 ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528
2707356epinephrine 8 MG per 250 ML InjectionSY61b0e2a2-71ed-43d6-b1a7-36d2dae651b528

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42023-315-0142023031501250 mL in 1 BAG250 mlHistorical
42023-315-104202303151010 BAG in 1 CARTON (42023-315-10) / 250 mL in 1 BAG (42023-315-01) 10 bag2024-10-04NoNoHistorical