FDA.reportPublic FDA data

Adrenalin

Product NDC
42023-168
11-digit product format
420230168
Labeler code
42023
Product ID
42023-168_1fbe8c4a-ff3c-48b6-b42f-19c948510266
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
epinephrine
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Par Health USA, LLC
Application
NDA204640
Marketing category
NDA
Marketing start
2020-12-04
Substance
EPINEPHRINE
Active strength
1 mg/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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYKH834O4BH
Rxcui310132, 1490057

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
42023-168-01Adrenalin30 mL in 1 VIALINJECTION3020
42023-168-01Adrenalin1 in 1 CARTONINJECTION120
42023-168-99Adrenalin30 mL in 1 VIALINJECTION3011
42023-168-99Adrenalin1 in 1 CARTONINJECTION111
42023-168-89Adrenalin30 mL in 1 VIALINJECTION3010
42023-168-89Adrenalin1 in 1 CARTONINJECTION110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-168-01ML - Milliliter42023-1682d49fdf1-d040-40f4-80b1-10d8e384af8012014-05-02
42023-168-99ML - Milliliter42023-168972cb46c-cb02-4b85-b913-5800df39d3c212021-01-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
epinephrineACTIVE INGREDIENTYKH834O4BHADRENALIN (EPINEPHRINE) INJECTION [PAR PHARMACEUTICAL, INC.]3
epinephrineACTIVE MOIETYYKH834O4BHADRENALIN (EPINEPHRINE) INJECTION [PAR PHARMACEUTICAL, INC.]3
chlorobutanolINACTIVE INGREDIENTHM4YQM8WRCADRENALIN (EPINEPHRINE) INJECTION [PAR PHARMACEUTICAL, INC.]3
hydrochloric acidINACTIVE INGREDIENTQTT17582CBADRENALIN (EPINEPHRINE) INJECTION [PAR PHARMACEUTICAL, INC.]3
sodium chlorideINACTIVE INGREDIENT451W47IQ8XADRENALIN (EPINEPHRINE) INJECTION [PAR PHARMACEUTICAL, INC.]3
sodium metabisulfiteINACTIVE INGREDIENT4VON5FNS3CADRENALIN (EPINEPHRINE) INJECTION [PAR PHARMACEUTICAL, INC.]3
waterINACTIVE INGREDIENT059QF0KO0RADRENALIN (EPINEPHRINE) INJECTION [PAR PHARMACEUTICAL, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42023-168ADRENALIN (EPINEPHRINE) INJECTION [ENDO USA, INC.]19Current NDC, Legacy NDC, 2 package rows20240425_3b7a4364-668d-4eb2-a20c-04adc35aabe4.zip
42023-168ADRENALIN (EPINEPHRINE) INJECTION [ENDO USA, INC.]8Current NDC, Legacy NDC, 2 package rows20241018_b27e06aa-5b40-44bc-8de7-80b027580a3b.zip
42023-168ADRENALIN (EPINEPHRINE) INJECTION [ENDO USA, INC.]7Current NDC, Legacy NDC, 2 package rows20241018_a5ce0c01-dd47-4997-ab09-490de65d3835.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1660016Adrenalin 1 MG in 1 ML InjectionPSN3b7a4364-668d-4eb2-a20c-04adc35aabe420
1490057Adrenalin 1 MG/ML Injectable SolutionPSN3b7a4364-668d-4eb2-a20c-04adc35aabe420
1660014EPINEPHrine 1 MG in 1 ML InjectionPSN3b7a4364-668d-4eb2-a20c-04adc35aabe420
310132EPINEPHrine 1 MG/ML (1:1000) Injectable SolutionPSN3b7a4364-668d-4eb2-a20c-04adc35aabe420
16600161 ML epinephrine 1 MG/ML Injection [Adrenalin]SBD3b7a4364-668d-4eb2-a20c-04adc35aabe420
1490057epinephrine 1 MG/ML Injectable Solution [Adrenalin]SBD3b7a4364-668d-4eb2-a20c-04adc35aabe420
16600141 ML epinephrine 1 MG/ML InjectionSCD3b7a4364-668d-4eb2-a20c-04adc35aabe420
310132epinephrine 1 MG/ML Injectable SolutionSCD3b7a4364-668d-4eb2-a20c-04adc35aabe420
16600161 ML Adrenalin 1 MG/ML InjectionSY3b7a4364-668d-4eb2-a20c-04adc35aabe420
1660016Adrenalin 1 MG per 1 ML InjectionSY3b7a4364-668d-4eb2-a20c-04adc35aabe420
1490057Adrenalin 1 MG/ML Injectable SolutionSY3b7a4364-668d-4eb2-a20c-04adc35aabe420
1490057Adrenalin 1:1000 Injectable SolutionSY3b7a4364-668d-4eb2-a20c-04adc35aabe420
1490057Adrenalin 30 MG per 30 ML Injectable SolutionSY3b7a4364-668d-4eb2-a20c-04adc35aabe420
310132epinephrine (as epinephrine hydrochloride) 1 MG/ML Injectable SolutionSY3b7a4364-668d-4eb2-a20c-04adc35aabe420
1660014epinephrine 1 MG per 1 ML InjectionSY3b7a4364-668d-4eb2-a20c-04adc35aabe420
310132epinephrine 1:1000 Injectable SolutionSY3b7a4364-668d-4eb2-a20c-04adc35aabe420
310132epinephrine 500 MCG per 0.5 ML Injectable SolutionSY3b7a4364-668d-4eb2-a20c-04adc35aabe420
1490057Adrenalin 1 MG/ML Injectable SolutionPSNb27e06aa-5b40-44bc-8de7-80b027580a3b11
310132EPINEPHrine 1 MG/ML (1:1000) Injectable SolutionPSNb27e06aa-5b40-44bc-8de7-80b027580a3b11
1490057epinephrine 1 MG/ML Injectable Solution [Adrenalin]SBDb27e06aa-5b40-44bc-8de7-80b027580a3b11
310132epinephrine 1 MG/ML Injectable SolutionSCDb27e06aa-5b40-44bc-8de7-80b027580a3b11
1490057Adrenalin 1 MG/ML Injectable SolutionSYb27e06aa-5b40-44bc-8de7-80b027580a3b11
1490057Adrenalin 1:1000 Injectable SolutionSYb27e06aa-5b40-44bc-8de7-80b027580a3b11
1490057Adrenalin 30 MG per 30 ML Injectable SolutionSYb27e06aa-5b40-44bc-8de7-80b027580a3b11
310132epinephrine (as epinephrine hydrochloride) 1 MG/ML Injectable SolutionSYb27e06aa-5b40-44bc-8de7-80b027580a3b11
310132epinephrine 1:1000 Injectable SolutionSYb27e06aa-5b40-44bc-8de7-80b027580a3b11
310132epinephrine 500 MCG per 0.5 ML Injectable SolutionSYb27e06aa-5b40-44bc-8de7-80b027580a3b11
1490057Adrenalin 1 MG/ML Injectable SolutionPSNa5ce0c01-dd47-4997-ab09-490de65d383510
310132EPINEPHrine 1 MG/ML (1:1000) Injectable SolutionPSNa5ce0c01-dd47-4997-ab09-490de65d383510
1490057epinephrine 1 MG/ML Injectable Solution [Adrenalin]SBDa5ce0c01-dd47-4997-ab09-490de65d383510
310132epinephrine 1 MG/ML Injectable SolutionSCDa5ce0c01-dd47-4997-ab09-490de65d383510
1490057Adrenalin 1 MG/ML Injectable SolutionSYa5ce0c01-dd47-4997-ab09-490de65d383510
1490057Adrenalin 1:1000 Injectable SolutionSYa5ce0c01-dd47-4997-ab09-490de65d383510
1490057Adrenalin 30 MG per 30 ML Injectable SolutionSYa5ce0c01-dd47-4997-ab09-490de65d383510
310132epinephrine (as epinephrine hydrochloride) 1 MG/ML Injectable SolutionSYa5ce0c01-dd47-4997-ab09-490de65d383510
310132epinephrine 1:1000 Injectable SolutionSYa5ce0c01-dd47-4997-ab09-490de65d383510
310132epinephrine 500 MCG per 0.5 ML Injectable SolutionSYa5ce0c01-dd47-4997-ab09-490de65d383510
310132EPINEPHrine 1 MG/ML (1:1000) Injectable SolutionPSN76462d55-5448-0fd0-e053-2991aa0aa49f4
310132epinephrine 1 MG/ML Injectable SolutionSCD76462d55-5448-0fd0-e053-2991aa0aa49f4
310132epinephrine (as epinephrine hydrochloride) 1 MG/ML Injectable SolutionSY76462d55-5448-0fd0-e053-2991aa0aa49f4
310132epinephrine 1:1000 Injectable SolutionSY76462d55-5448-0fd0-e053-2991aa0aa49f4
310132epinephrine 500 MCG per 0.5 ML Injectable SolutionSY76462d55-5448-0fd0-e053-2991aa0aa49f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42023-168-01420230168011 VIAL in 1 CARTON (42023-168-01) / 30 mL in 1 VIAL1 vial2014-03-010000-00-00NoNoCurrent
42023-168-89420230168891 VIAL in 1 CARTON (42023-168-89) / 30 mL in 1 VIAL1 vial2020-12-040000-00-00NoNoCurrent
42023-168-99420230168991 VIAL in 1 CARTON (42023-168-99) / 30 mL in 1 VIAL1 vial2020-12-040000-00-00NoNoCurrent