Epinephrine Auto-Injector

Brand(s)
Adrenaclick, Auvi-Q, Epipen
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Amedra Pharmaceuticals Llc (2014-10-17)
Oldest Current Product
1987-12-22
License(s)
NDA, NDA AUTHORIZED GENERIC
RxNORM
AUTO-INJECTOR\EPINEPHRINE
FDAOB
INTRAMUSCULAR, SUBCUTANEOUS\INJECTION\EPINEPHRINE\rdfq
INTRAMUSCULAR\INJECTION\EPINEPHRINE
SPL Active
INTRAMUSCULAR\INJECTION\EPINEPHRINE
SUBCUTANEOUS\INJECTION\EPINEPHRINE
SPL Moiety
INTRAMUSCULAR\INJECTION\EPINEPHRINE
SUBCUTANEOUS\INJECTION\EPINEPHRINE

product(s) by strength(s)

0.3 ml epinephrine 0.5 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1495020501EpipenNDAMylan Specialty L.P.1987-12-22EPINEPHRINEINTRAMUSCULARINJECTIONNDA0194307560c201-9246-487c-a13b-6295db04274a

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684819EpipenNDAPhysicians Total Care, Inc.2003-06-17EPINEPHRINEINTRAMUSCULARINJECTION495020501NDA019430e47dc072-9cab-468e-851c-08c01652f447
2550453598EpipenNDADispensing Solutions, Inc.1987-12-22EPINEPHRINEINTRAMUSCULARINJECTION495020501NDA0194306d0fc046-a2d4-4bca-b8f2-f24161a1bf73
3647250501EpipenNDATya Pharmaceuticals1987-12-22EPINEPHRINEINTRAMUSCULARINJECTION495020501NDA019430cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6

0.3 ml epinephrine 1 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1495020500EpipenNDAMylan Specialty L.P.1987-12-22EPINEPHRINEINTRAMUSCULARINJECTIONNDA0194307560c201-9246-487c-a13b-6295db04274a
2520540804AdrenaclickNDAAmedra Pharmaceuticals Llc2009-11-25EPINEPHRINESUBCUTANEOUSINJECTIONNDA020800ddee42e1-7e9e-4d2e-83ed-2e501b0dac25

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1545050102NDA AUTHORIZED GENERICLineage Therapeutics Inc2010-04-01EPINEPHRINESUBCUTANEOUSINJECTIONNDA020800ee3b44c1-b8b1-11e2-9e96-0800200c9a66

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1216950947NDA AUTHORIZED GENERICRebel Distributors Corp2010-03-31EPINEPHRINESUBCUTANEOUSINJECTION597620171NDA020800ad07e9bf-cc81-4736-86c7-2b2de9386eb2
2493490747EpipenNDARemedyrepack Inc.2013-06-11, 2013-09-27EPINEPHRINEINTRAMUSCULARINJECTION495020500NDA01943098e682d5-8efa-41f3-8bee-7853cbffe66f, e9a43a7e-bfd2-4dbc-91b7-f09a07c22b26
3548682804EpipenNDAPhysicians Total Care, Inc.2003-06-17EPINEPHRINEINTRAMUSCULARINJECTION495020500NDA019430e47dc072-9cab-468e-851c-08c01652f447
4548686239NDAPhysicians Total Care, Inc.2011-04-18EPINEPHRINESUBCUTANEOUSINJECTION597620171NDA020800fee44162-aaf2-4e89-9f83-2d3a8ff76760
5550453207EpipenNDADispensing Solutions, Inc.1987-12-22EPINEPHRINEINTRAMUSCULARINJECTION495020500NDA019430f3f1a483-e29a-4e3e-b677-16fa87fe5e5a
6647250500EpipenNDATya Pharmaceuticals1987-12-22EPINEPHRINEINTRAMUSCULARINJECTION495020500NDA019430cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6

0.15 ml epinephrine 1 mg/ml auto-injector

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000245831Auvi-QNDASanofi-Aventis U.S. Llc2012-11-15EPINEPHRINEINTRAMUSCULARINJECTIONNDA2017394c550991-c4cf-11df-851a-0800200c9a66

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1545050101NDA AUTHORIZED GENERICLineage Therapeutics Inc2010-04-01EPINEPHRINESUBCUTANEOUSINJECTIONNDA020800ee3b44c1-b8b1-11e2-9e96-0800200c9a66

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 Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
2NDA020800ADRENACLICKAMEDRA PHARMACEUTICALS LLC2003-05-30p7297136, SUBSTANCE
p7621891, SUBSTANCE
NDA020800_001, NDA020800_002, NDA020800_003, NDA020800_004Epinephrine Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
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 Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
4NDA204640ADRENALINPAR STERILE PRODUCTS LLC2013-12-18p9119876, SUBSTANCENDA204640_001Epinephrine Injection
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution

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

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14c550991-c4cf-11df-851a-0800200c9a66 (view SPL)These highlights do not include all the information needed to use AuviQ safely and effectively. See full prescribing information for AuviQ. AuviQ (epinephrine injection, USP) 0.3 mg, 0.15 mg Auto-Injector Initial U.S. Approval: 2012prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2014-02-149000245831, 000245833
26d0fc046-a2d4-4bca-b8f2-f24161a1bf73 (view SPL)EpiPen (epinephrine) Auto-Injector 0.3 mgEpiPen = one dose of 0.30 mg epinephrine (USP, 1:1000, 0.3 mL)EpiPen JR(epinephrine) Auto-Injector 0.15 mgEpiPen Jr = one dose of 0.15 mg epinephrine (USP, 1:2000, 0.3 mL)prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2012-02-011550453598
37560c201-9246-487c-a13b-6295db04274a (view SPL)These highlights do not include all the information needed to use EPIPEN and EPIPEN Jr safely and effectively. See full prescribing information for EPIPEN and EPIPEN Jr.EPIPEN (epinephrine injection), Auto-Injector 0.3 mg, EPIPEN Jr (epinephrine injection) Auto-Injector 0.15 mg, for intramuscular or subcutaneous useInitial U.S. Approval: 1939prescriptionHuman PrescriptionMylan Specialty L.P.2014-04-0813495020500, 495020501
498e682d5-8efa-41f3-8bee-7853cbffe66f (view SPL)EPIPEN(epinephrine) Auto-Injector 0.3 mgEpipen = one dose of 0.30 mg epinephrine (USP, 1:1000, 0.3 mL)EPIPEN JR(epinephrine) Auto-Injector 0.15 mgEpipen Jr = one dose of 0.15 mg epinephrine (USP, 1:2000, 0.3 mL)PRESCRIBING INFORMATIONprescriptionHuman PrescriptionRemedyrepack Inc.2013-06-111493490747
5ad07e9bf-cc81-4736-86c7-2b2de9386eb2 (view SPL)epinephrine injection, USP auto-injectorprescriptionHuman PrescriptionRebel Distributors CorpRELABEL, REPACK2011-07-221216950947
6cb1b0dc7-6f5f-45fc-96c7-a6006b88fdc6 (view SPL)These highlights do not include all the information needed to use safely and effectively. See full prescribing information for . Initial U.S. Approval: 1939 EPIPEN and EPIPEN Jr EPIPEN and EPIPEN Jr EPIPEN (epinephrine injection), Auto-Injector 0.3 mg, EPIPEN Jr (epinephrine injection) Auto-Injector 0.15 mg, for intramuscular or subcutaneous use prescriptionHuman PrescriptionTya PharmaceuticalsRELABEL, REPACK2014-05-014647250500, 647250501
7ddee42e1-7e9e-4d2e-83ed-2e501b0dac25 (view SPL)These highlights do not include all the information needed to use ADRENACLICK safely and effectively. See full prescribing information for ADRENACLICK. ADRENACLICK (epinephrine injection) 0.3 mg, 0.15 mg Auto-Injector, for intramuscular or subcutaneous use Initial U.S. Approval: 1939prescriptionHuman PrescriptionAmedra Pharmaceuticals Llc2014-10-176520540804, 520540803
8e47dc072-9cab-468e-851c-08c01652f447 (view SPL)EpiPen (epinephrine) Auto-Injector 0.3 mgEpiPen = one dose of 0.30 mg epinephrine (USP, 1:1000, 0.3 mL)EpiPen JR(epinephrine) Auto-Injector 0.15 mgEpiPen Jr = one dose of 0.15 mg epinephrine (USP, 1:2000, 0.3 mL)prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2012-05-142548682804, 548684819
9e9a43a7e-bfd2-4dbc-91b7-f09a07c22b26 (view SPL)EPIPEN(epinephrine) Auto-Injector 0.3 mgEpipen = one dose of 0.30 mg epinephrine (USP, 1:1000, 0.3 mL)EPIPEN JR(epinephrine) Auto-Injector 0.15 mgEpipen Jr = one dose of 0.15 mg epinephrine (USP, 1:2000, 0.3 mL)PRESCRIBING INFORMATIONprescriptionHuman PrescriptionRemedyrepack Inc.2013-09-272493490747
10ee3b44c1-b8b1-11e2-9e96-0800200c9a66 (view SPL)These highlights do not include all the information needed to use EPINEPHRINE INJECTION, USP AUTO-INJECTOR safely and effectively. See full prescribing information for EPINEPHRINE INJECTION, USP AUTO-INJECTOR. Epinephrine injection, USP auto-injector 0.3 mg, 0.15 mg, for intramuscular or subcutaneous use Initial U.S. Approval: 1939prescriptionHuman PrescriptionLineage Therapeutics Inc2014-10-177545050101, 545050102
11f3f1a483-e29a-4e3e-b677-16fa87fe5e5a (view SPL)EpiPen (epinephrine) Auto-Injector 0.3 mgEpiPen = one dose of 0.30 mg epinephrine (USP, 1:1000, 0.3 mL)EpiPen JR(epinephrine) Auto-Injector 0.15 mgEpiPen Jr = one dose of 0.15 mg epinephrine (USP, 1:2000, 0.3 mL)prescriptionHuman PrescriptionDispensing Solutions, Inc.relabel, repack2012-09-252550453207
12fee44162-aaf2-4e89-9f83-2d3a8ff76760 (view SPL)epinephrine injection, USP auto-injectorprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2011-02-161548686239

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