Epinephrine Injectable Solution

Brand(s)
Adrenalin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
International Medication Systems, Limited (2015-05-13)
Oldest Current Product
1994-03-01
License(s)
UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTABLE SOLUTION\EPINEPHRINE
FDAOB
INTRAMUSCULAR, SUBCUTANEOUS\INJECTION\EPINEPHRINE\rdfq
INTRAMUSCULAR\INJECTION\EPINEPHRINE
SPL Active
INTRACARDIAC\INJECTION, SOLUTION\EPINEPHRINE
INTRAMUSCULAR\INJECTION, SOLUTION\EPINEPHRINE HYDROCHLORIDE
PARENTERAL\INJECTION\EPINEPHRINE
SPL Moiety
INTRACARDIAC\INJECTION, SOLUTION\EPINEPHRINE
INTRAMUSCULAR\INJECTION, SOLUTION\EPINEPHRINE
PARENTERAL\INJECTION\EPINEPHRINE

product(s) by strength(s)

epinephrine 1 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1448270301UNAPPROVED DRUG OTHER MARKETING CATEGORYValesco Pharmaceuticals Llc.1994-03-01EPINEPHRINE HYDROCHLORIDEINTRAMUSCULARINJECTION, SOLUTION3ed35d7d-616c-43cd-9776-705821afc1f0
2763299061UNAPPROVED DRUG OTHER MARKETING CATEGORYInternational Medication Systems, Limited2000-07-01EPINEPHRINEPARENTERALINJECTION070d391a-0525-4172-add9-5cb45e0c5d67

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productspl
1525840019UNAPPROVED DRUG OTHER MARKETING CATEGORYGeneral Injecatables & Vaccines, Inc2010-07-01EPINEPHRINEINTRACARDIACINJECTION, SOLUTION0051711300babff47-11ed-47b6-a57d-502ca3c86973

application(s)

#idtitleapplicantapprovedpatentapproved drugin other drug docs
1NDA019430EPI E Z PEN JRMYLAN SPECIALTY LP1987-12-22p8048035, SUBSTANCE
p7449012, SUBSTANCE
p7794432, SUBSTANCE
p8870827, SUBSTANCE
NDA019430_001, NDA019430_002, NDA019430_003, NDA019430_004Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
2NDA020800ADRENACLICKAMEDRA PHARMACEUTICALS LLC2003-05-30p7297136, SUBSTANCE
p7621891, SUBSTANCE
NDA020800_001, NDA020800_002, NDA020800_003, NDA020800_004Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
3NDA201739AUVI-QSANOFI AVENTIS US LLC2012-08-10p9149579, METHOD OF TREATING ALLERGIC REACTION VIA INJECTION
p8206360, SUBSTANCE
p8021344, SUBSTANCE
p7731690, SUBSTANCE
p8313466, SUBSTANCE
p8226610, SUBSTANCE
p7918823, SUBSTANCE
p8425462, SUBSTANCE
p7731686, SUBSTANCE
p8361029, SUBSTANCE
p8231573, SUBSTANCE
p7749194, SUBSTANCE
p8926594, SUBSTANCE
p9056170, SUBSTANCE
p8920377, SUBSTANCE
p8016788, SUBSTANCE
p8608698, SUBSTANCE
p7947017, SUBSTANCE
NDA201739_001, NDA201739_002Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
4NDA204640ADRENALINPAR STERILE PRODUCTS LLC2013-12-18p9119876, SUBSTANCENDA204640_001Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1NDA019430_001RXEPINEPHRINE (0.3MG/DELIVERY)INJECTIONTrueBX1987-12-22EPI E Z PEN JR
2NDA019430_002RXEPINEPHRINE (0.15MG/DELIVERY)INJECTIONTrueBX1987-12-22EPI E Z PEN JR
3NDA019430_003discontinuedEPINEPHRINE (0.3MG/DELIVERY)INTRAMUSCULARINJECTIONFalse1995-08-03EPI E Z PEN JR
4NDA019430_004discontinuedEPINEPHRINE (0.15MG/DELIVERY)INTRAMUSCULARINJECTIONFalse1995-08-03EPI E Z PEN JR
5NDA020800_001RXEPINEPHRINE (EQ 0.3MG/DELIVERY)INJECTIONTrueBX2003-05-30ADRENACLICK
6NDA020800_002RXEPINEPHRINE (EQ 0.15MG/DELIVERY)INJECTIONTrueBX2004-05-28ADRENACLICK
7NDA020800_003RXEPINEPHRINE (EQ 0.15MG/DELIVERY)INJECTIONTrueBX2009-11-25ADRENACLICK
8NDA020800_004RXEPINEPHRINE (EQ 0.3MG/DELIVERY)INJECTIONTrueBX2009-11-25ADRENACLICK
9NDA201739_001RXEPINEPHRINE (EQ 0.3MG/DELIVERY)INJECTIONFalseBX2012-08-10AUVI-Q
10NDA201739_002RXEPINEPHRINE (EQ 0.15MG/DELIVERY)INJECTIONTrueBX2012-08-10AUVI-Q
11NDA204640_001RXEPINEPHRINE (EQ 30MG BASE/30ML)INJECTIONTrue2013-12-18ADRENALIN

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7297136 (view patent)2025-01-18NDA020800Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
2p7449012 (view patent)2025-09-11NDA019430Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
3p7621891 (view patent)2025-02-04NDA020800Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
4p7731686 (view patent)2026-06-01NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Naloxone Auto-Injector
5p7731690 (view patent)2025-01-15NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Naloxone Auto-Injector
6p7749194 (view patent)2028-10-30NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Naloxone Auto-Injector
7p7794432 (view patent)2025-09-11NDA019430Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
8p7918823 (view patent)2024-11-23NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Naloxone Auto-Injector
9p7947017 (view patent)2028-03-12NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Naloxone Auto-Injector
10p8016788 (view patent)2025-03-21NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Naloxone Auto-Injector
11p8021344 (view patent)2029-11-02NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Naloxone Auto-Injector
12p8048035 (view patent)2025-09-11NDA019430Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
13p8206360 (view patent)2027-02-27NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Naloxone Auto-Injector
14p8226610 (view patent)2029-04-10NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Naloxone Auto-Injector
15p8231573 (view patent)2028-11-25NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Naloxone Auto-Injector
16p8313466 (view patent)2024-11-23NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Naloxone Auto-Injector
17p8361029 (view patent)2024-11-23NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Naloxone Auto-Injector
18p8425462 (view patent)2024-11-23NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Naloxone Auto-Injector
19p8608698 (view patent)2024-11-23NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Naloxone Auto-Injector
20p8870827 (view patent)2025-09-11NDA019430Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
21p8920377 (view patent)2024-11-23NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
22p8926594 (view patent)2026-03-31NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Naloxone Auto-Injector
23p9056170 (view patent)2024-11-23NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
Naloxone Auto-Injector
24p9119876 (view patent)2035-03-13NDA204640Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe
25p9149579 (view patent)2025-07-19NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Prefilled Syringe

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1070d391a-0525-4172-add9-5cb45e0c5d67 (view SPL)prescriptionHuman PrescriptionInternational Medication Systems, Limitedanalysis, label, manufacture2015-05-133763299061
20babff47-11ed-47b6-a57d-502ca3c86973 (view SPL)prescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2012-03-272525840019
33b7a4364-668d-4eb2-a20c-04adc35aabe4 (view SPL)These highlights do not include all the information needed to use ADRENALIN safely and effectively. See full prescribing information for ADRENALIN. ADRENALIN (epinephrine injection) 1 mg/mL (1:1000) 1mL vial: for intramuscular, subcutaneous, and intraocular use 30 mL vial: for intramuscular and subcutaneous use Initial U.S. Approval: 1939prescriptionHuman PrescriptionPar Pharmaceutical Inc.2015-09-183420230159, 420230168Epinephrine Injection
43ed35d7d-616c-43cd-9776-705821afc1f0 (view SPL)prescriptionHuman PrescriptionValesco Pharmaceuticals Llc.2014-02-243448270301
57b3d99dc-cb35-4331-96cd-fedb95b96750 (view SPL)EPINEPHRINE INJECTION, USP, 1:1000prescriptionHuman PrescriptionAmphastar Pharmaceuticals, Inc.2009-12-151005489061

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII