FDA.reportPublic FDA data

Adrenalin

Product NDC
42023-159
11-digit product format
420230159
Labeler code
42023
Product ID
42023-159_da9a4e0e-1f51-4f21-8077-c6e98e29280a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
epinephrine
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS; SUBCUTANEOUS
Labeler
Par Health USA, LLC
Application
NDA204200
Marketing category
NDA
Marketing start
2013-07-01
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Adrenalin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EPINEPHRINE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYKH834O4BH
Rxcui310132, 1490057, 1660014, 1660016

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42023-159-01Adrenalin1 mL in 1 VIALINJECTION120
42023-159-25Adrenalin25 in 1 CARTONINJECTION2520
42023-159-01Certa Dose Epinephrine Convenience Kit1 mL in 1 VIALINJECTION1 mL1 mg in 1mL9
42023-159-01EpinephrineSnap-EMS1 mL in 1 VIALINJECTION1 mL1 mg in 1mL8
42023-159-25Epinephrine Professional1 mL in 1 VIALINJECTION1 mL1 mg in 1mL7
42023-159-01Epinephrine Professional EMS1 mL in 1 VIALINJECTION1 mL1 mg in 1mL6
42023-159-25EpinephrineSnap-V1 mL in 1 VIALINJECTION1 mL1 mg in 1mL6
42023-159-25epinephrinesnap-v1 mL in 1 VIAL, GLASSINJECTION1 mL1 mg in 1mL2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42023-159-01ML - Milliliter42023-159705b9b94-a709-442a-85b8-29b76c05965012019-10-07
42023-159-25ML - Milliliter42023-1594e6f8ea2-eb3e-4b59-aa0b-e6f6bb39801512013-09-04

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
42023-159ADRENALIN (EPINEPHRINE) INJECTION [ENDO USA, INC.]19Current NDC, Legacy NDC, 2 package rows20240425_3b7a4364-668d-4eb2-a20c-04adc35aabe4.zip
42023-159CERTA DOSE EPINEPHRINE CONVENIENCE KIT (EPINEPHRINE CONVENIENCE KIT) KIT [CD ACQUISITIONS, LLC]9Current NDC, Legacy NDC20250101_780ca016-d85c-6fac-e053-2a91aa0abd0b.zip
42023-159EPINEPHRINESNAP-EMS (EPINEPHRINE CONVENIENCE KIT) KIT [SNAP MEDICAL INDUSTRIES]8Current NDC, Legacy NDC20220114_77b974f7-e3be-0d6b-e053-2991aa0a65fd.zip
42023-159EPINEPHRINE PROFESSIONAL (EPINEPHRINE AND ISOPROPYL ALCOHOL) KIT [FOCUS HEALTH GROUP]6Current NDC, Legacy NDC20241025_8c502fcc-1b61-7d1f-e053-2a95a90adc46.zip
42023-159EPINEPHRINE PROFESSIONAL EMS (EPINEPHRINE CONVENIENCE KIT) KIT [FOCUS HEALTH GROUP]6Current NDC, Legacy NDC20230412_8d4491fa-aaf8-37b6-e053-2a95a90a3f9e.zip
42023-159EPINEPHRINESNAP-V (EPINEPHRINE CONVENIENCE KIT) KIT [SNAP MEDICAL INDUSTRIES]6Current NDC, Legacy NDC20220114_791025c6-5425-c68d-e053-2a91aa0a2bc5.zip
42023-159EPINEPHRINESNAP-V (EPINEPHRINE CONVENIENCE KIT) KIT [FOCUS HEALTH GROUP]2Current NDC, Legacy NDC20180328_580d1baa-cfdd-f3e7-e053-2a91aa0ac059.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1660016Adrenalin 1 MG in 1 ML InjectionPSN28649937-8ae1-a022-e063-6394a90aebe021
1660014EPINEPHrine 1 MG in 1 ML InjectionPSN28649937-8ae1-a022-e063-6394a90aebe021
16600161 ML epinephrine 1 MG/ML Injection [Adrenalin]SBD28649937-8ae1-a022-e063-6394a90aebe021
16600141 ML epinephrine 1 MG/ML InjectionSCD28649937-8ae1-a022-e063-6394a90aebe021
16600161 ML Adrenalin 1 MG/ML InjectionSY28649937-8ae1-a022-e063-6394a90aebe021
1660016Adrenalin 1 MG per 1 ML InjectionSY28649937-8ae1-a022-e063-6394a90aebe021
1660014epinephrine 1 MG per 1 ML InjectionSY28649937-8ae1-a022-e063-6394a90aebe021
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
1660016Adrenalin 1 MG in 1 ML InjectionPSN1d89cba4-432b-4a98-8969-5a019dced8d112
1660014EPINEPHrine 1 MG in 1 ML InjectionPSN1d89cba4-432b-4a98-8969-5a019dced8d112
16600161 ML epinephrine 1 MG/ML Injection [Adrenalin]SBD1d89cba4-432b-4a98-8969-5a019dced8d112
16600141 ML epinephrine 1 MG/ML InjectionSCD1d89cba4-432b-4a98-8969-5a019dced8d112
16600161 ML Adrenalin 1 MG/ML InjectionSY1d89cba4-432b-4a98-8969-5a019dced8d112
1660016Adrenalin 1 MG per 1 ML InjectionSY1d89cba4-432b-4a98-8969-5a019dced8d112
1660014epinephrine 1 MG per 1 ML InjectionSY1d89cba4-432b-4a98-8969-5a019dced8d112
1660016Adrenalin 1 MG in 1 ML InjectionPSN780ca016-d85c-6fac-e053-2a91aa0abd0b9
1660014EPINEPHrine 1 MG in 1 ML InjectionPSN780ca016-d85c-6fac-e053-2a91aa0abd0b9
1660014EPINEPHrine 1 MG in 1 ML InjectionPSN7663c49d-1b1d-755d-e053-2991aa0a4ee39
16600161 ML epinephrine 1 MG/ML Injection [Adrenalin]SBD780ca016-d85c-6fac-e053-2a91aa0abd0b9
16600141 ML epinephrine 1 MG/ML InjectionSCD780ca016-d85c-6fac-e053-2a91aa0abd0b9
16600141 ML epinephrine 1 MG/ML InjectionSCD7663c49d-1b1d-755d-e053-2991aa0a4ee39
16600161 ML Adrenalin 1 MG/ML InjectionSY780ca016-d85c-6fac-e053-2a91aa0abd0b9
1660016Adrenalin 1 MG per 1 ML InjectionSY780ca016-d85c-6fac-e053-2a91aa0abd0b9
1660014epinephrine 1 MG per 1 ML InjectionSY780ca016-d85c-6fac-e053-2a91aa0abd0b9
1660014epinephrine 1 MG per 1 ML InjectionSY7663c49d-1b1d-755d-e053-2991aa0a4ee39
1660016Adrenalin 1 MG in 1 ML InjectionPSN77b974f7-e3be-0d6b-e053-2991aa0a65fd8
1660014EPINEPHrine 1 MG in 1 ML InjectionPSN77b974f7-e3be-0d6b-e053-2991aa0a65fd8
797544isopropyl alcohol 70 % Medicated PadPSN77b974f7-e3be-0d6b-e053-2991aa0a65fd8
16600161 ML epinephrine 1 MG/ML Injection [Adrenalin]SBD77b974f7-e3be-0d6b-e053-2991aa0a65fd8
16600141 ML epinephrine 1 MG/ML InjectionSCD77b974f7-e3be-0d6b-e053-2991aa0a65fd8
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD77b974f7-e3be-0d6b-e053-2991aa0a65fd8
16600161 ML Adrenalin 1 MG/ML InjectionSY77b974f7-e3be-0d6b-e053-2991aa0a65fd8
1660016Adrenalin 1 MG per 1 ML InjectionSY77b974f7-e3be-0d6b-e053-2991aa0a65fd8
1660014epinephrine 1 MG per 1 ML InjectionSY77b974f7-e3be-0d6b-e053-2991aa0a65fd8
797544isopropyl alcohol 70 % Medicated PadSY77b974f7-e3be-0d6b-e053-2991aa0a65fd8
797544isopropyl alcohol 70 % Topical ClothSY77b974f7-e3be-0d6b-e053-2991aa0a65fd8
797544isopropyl alcohol 70 % Topical SwabSY77b974f7-e3be-0d6b-e053-2991aa0a65fd8
1660016Adrenalin 1 MG in 1 ML InjectionPSN8c502fcc-1b61-7d1f-e053-2a95a90adc467
1660014EPINEPHrine 1 MG in 1 ML InjectionPSN8c502fcc-1b61-7d1f-e053-2a95a90adc467
797544isopropyl alcohol 70 % Medicated PadPSN8c502fcc-1b61-7d1f-e053-2a95a90adc467
16600161 ML epinephrine 1 MG/ML Injection [Adrenalin]SBD8c502fcc-1b61-7d1f-e053-2a95a90adc467
16600141 ML epinephrine 1 MG/ML InjectionSCD8c502fcc-1b61-7d1f-e053-2a95a90adc467
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD8c502fcc-1b61-7d1f-e053-2a95a90adc467
16600161 ML Adrenalin 1 MG/ML InjectionSY8c502fcc-1b61-7d1f-e053-2a95a90adc467
1660016Adrenalin 1 MG per 1 ML InjectionSY8c502fcc-1b61-7d1f-e053-2a95a90adc467
1660014epinephrine 1 MG per 1 ML InjectionSY8c502fcc-1b61-7d1f-e053-2a95a90adc467
797544isopropyl alcohol 70 % Medicated PadSY8c502fcc-1b61-7d1f-e053-2a95a90adc467
797544isopropyl alcohol 70 % Topical ClothSY8c502fcc-1b61-7d1f-e053-2a95a90adc467
797544isopropyl alcohol 70 % Topical SwabSY8c502fcc-1b61-7d1f-e053-2a95a90adc467
1660016Adrenalin 1 MG in 1 ML InjectionPSNb293ad8e-7055-4a95-a130-9d7d74f19eab6
1660016Adrenalin 1 MG in 1 ML InjectionPSN791025c6-5425-c68d-e053-2a91aa0a2bc56
1660016Adrenalin 1 MG in 1 ML InjectionPSN8d4491fa-aaf8-37b6-e053-2a95a90a3f9e6
1660014EPINEPHrine 1 MG in 1 ML InjectionPSN8d4491fa-aaf8-37b6-e053-2a95a90a3f9e6
1660014EPINEPHrine 1 MG in 1 ML InjectionPSNb293ad8e-7055-4a95-a130-9d7d74f19eab6
1660014EPINEPHrine 1 MG in 1 ML InjectionPSN791025c6-5425-c68d-e053-2a91aa0a2bc56
797544isopropyl alcohol 70 % Medicated PadPSN791025c6-5425-c68d-e053-2a91aa0a2bc56
797544isopropyl alcohol 70 % Medicated PadPSN8d4491fa-aaf8-37b6-e053-2a95a90a3f9e6
16600161 ML epinephrine 1 MG/ML Injection [Adrenalin]SBD8d4491fa-aaf8-37b6-e053-2a95a90a3f9e6
16600161 ML epinephrine 1 MG/ML Injection [Adrenalin]SBD791025c6-5425-c68d-e053-2a91aa0a2bc56
16600161 ML epinephrine 1 MG/ML Injection [Adrenalin]SBDb293ad8e-7055-4a95-a130-9d7d74f19eab6
16600141 ML epinephrine 1 MG/ML InjectionSCD8d4491fa-aaf8-37b6-e053-2a95a90a3f9e6
16600141 ML epinephrine 1 MG/ML InjectionSCD791025c6-5425-c68d-e053-2a91aa0a2bc56
16600141 ML epinephrine 1 MG/ML InjectionSCDb293ad8e-7055-4a95-a130-9d7d74f19eab6
797544isopropyl alcohol 0.7 ML/ML Medicated PadSCD8d4491fa-aaf8-37b6-e053-2a95a90a3f9e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42023-159-01420230159011 mL in 1 VIAL1 mlHistorical
42023-159-254202301592525 VIAL in 1 CARTON (42023-159-25) / 1 mL in 1 VIAL (42023-159-01) 25 vial2013-07-010000-00-00NoNoCurrent