Epinephrine Injection

Brand(s)
Adrenalin
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Belcher Pharmaceuticals,Llc (2015-11-04)
Oldest Current Product
2010-03-01
License(s)
NDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
INJECTION\EPINEPHRINE
FDAOB
INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUS\INJECTION\EPINEPHRINE\rdfq
INTRAMUSCULAR, SUBCUTANEOUS\INJECTION\EPINEPHRINE\rdfq
INTRAMUSCULAR\INJECTION\EPINEPHRINE
IV (INFUSION), INTRAOCULAR\SOLUTION\EPINEPHRINE HYDROCHLORIDE\rdfq
SPL Active
ENDOTRACHEAL\INJECTION\EPINEPHRINE
INTRACARDIAC\INJECTION, SOLUTION\EPINEPHRINE
INTRAMUSCULAR\INJECTION, SOLUTION\EPINEPHRINE
INTRAMUSCULAR\INJECTION\EPINEPHRINE
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\EPINEPHRINE
SUBCUTANEOUS\INJECTION, SOLUTION\EPINEPHRINE
SPL Moiety
ENDOTRACHEAL\INJECTION\EPINEPHRINE
INTRACARDIAC\INJECTION, SOLUTION\EPINEPHRINE
INTRAMUSCULAR\INJECTION, SOLUTION\EPINEPHRINE
INTRAMUSCULAR\INJECTION\EPINEPHRINE
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\EPINEPHRINE
SUBCUTANEOUS\INJECTION, SOLUTION\EPINEPHRINE

product(s) by strength(s)

1 ml epinephrine 1 mg/ml injection

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1542880103NDABpi Labs, Llc2014-08-08EPINEPHRINEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATENDA2050295b5282a9-b149-4f0a-978e-5adbf48ec8aa
2622500103NDABelcher Pharmaceuticals,Llc2014-08-08EPINEPHRINEINTRAVENOUSINJECTION, SOLUTION, CONCENTRATENDA205029e51c9ca2-6057-4830-9dcc-e8c7491f861b

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1521250785UNAPPROVED DRUG OTHER MARKETING CATEGORYRemedyrepack Inc.2015-09-17EPINEPHRINESUBCUTANEOUSINJECTION, SOLUTION00409724144135025-f41a-4d6c-8ec4-20bef27f144d
2525840241NDAGeneral Injecatables & Vaccines, Inc2010-03-01EPINEPHRINEINTRAMUSCULARINJECTION, SOLUTION004097241NDA0208000c07b20c-d222-4b42-87b8-9667705a2945
3551542381UNAPPROVED DRUG OTHER MARKETING CATEGORYCardinal Health2013-05-08EPINEPHRINEENDOTRACHEALINJECTION00409724174b3e639-cd9d-46b0-8505-86b0214cb20b
4617860242AdrenalinNDARemedyrepack Inc.2015-03-25EPINEPHRINEINTRAMUSCULARINJECTION420230159NDA204200ff31db75-1935-43df-9cd7-a63297d78cf5
5637390467UNAPPROVED DRUG OTHER MARKETING CATEGORYMckesson Packaging Services A Business Unit Of Mckesson Corporation2010-05-03EPINEPHRINEINTRACARDIACINJECTION, SOLUTION004097241d785beac-3f68-4df1-926f-34da6773f295

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 Prefilled Syringe
Epinephrine Injectable Solution
2NDA020800ADRENACLICKAMEDRA PHARMACEUTICALS LLC2003-05-30p7297136, SUBSTANCE
p7621891, SUBSTANCE
NDA020800_001, NDA020800_002, NDA020800_003, NDA020800_004Epinephrine Auto-Injector
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 Auto-Injector
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
4NDA204200ADRENALINPAR STERILE PRODUCTS LLC2012-12-07NDA204200_001
5NDA204640ADRENALINPAR STERILE PRODUCTS LLC2013-12-18p9119876, SUBSTANCENDA204640_001Epinephrine Auto-Injector
Epinephrine Prefilled Syringe
Epinephrine Injectable Solution
6NDA205029EPINEPHRINEBELCHER PHARMACEUTICALS LLC2014-07-29NDA205029_001

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
11NDA204200_001RXEPINEPHRINE (EQ 1MG BASE/ML)INJECTIONTrue2012-12-07ADRENALIN
12NDA204640_001RXEPINEPHRINE (EQ 30MG BASE/30ML)INJECTIONTrue2013-12-18ADRENALIN
13NDA205029_001RXEPINEPHRINE HYDROCHLORIDE (EQ 1MG BASE/ML)SOLUTIONFalse2014-07-29EPINEPHRINE

patent(s)

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

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
10c07b20c-d222-4b42-87b8-9667705a2945 (view SPL)Epinephrine 1:1000 1 mg/mL Injection, USP 1 mL 5 PK Single Dose AmpuleprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-07-151525840241
23b7a4364-668d-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 Injectable Solution
344135025-f41a-4d6c-8ec4-20bef27f144d (view SPL)EPINEPHRINEInjection, USPprescriptionHuman PrescriptionRemedyrepack Inc.2015-09-171521250785
45b5282a9-b149-4f0a-978e-5adbf48ec8aa (view SPL)These highlights do not include all the information needed to use EPINEPHRINE INJECTION USP safely and effectively. See full prescribing information for EPINEPHRINE INJECTION USP. EPINEPHRINE INJECTION USP, 1 mg/mL (1:1,000) ampule for IV infusion Initial U.S. Approval: 1939prescriptionHuman PrescriptionBpi Labs, LlcANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2014-07-231542880103
574b3e639-cd9d-46b0-8505-86b0214cb20b (view SPL)Epinephrine Injection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2014-06-243551542381
68da22eb1-0965-4d4e-b15d-91db7193548e (view SPL)EPINEPHRINEInjection, USPprescriptionHuman PrescriptionHospira, Inc.2014-05-022004097241
7d785beac-3f68-4df1-926f-34da6773f295 (view SPL)Epinephrine Injection, USP1:1000 (1 mg/mL)AmpulProtect from light until ready to use.prescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationMANUFACTURE, REPACK2010-05-121637390467
8e51c9ca2-6057-4830-9dcc-e8c7491f861b (view SPL)These highlights do not include all the information needed to use EPINEPHRINE INJECTION USP safely and effectively. See full prescribing information for EPINEPHRINE INJECTION USP. EPINEPHRINE INJECTION USP, 1 mg/mL (1:1,000) ampule for IV infusion and intraocular use Initial U.S. Approval: 1939prescriptionHuman PrescriptionBelcher Pharmaceuticals,LlcANALYSIS, API MANUFACTURE, LABEL, MANUFACTURE, PACK2015-11-045622500103
9fd5ede55-10de-491e-a73f-17a77f89891a (view SPL)EPINEPHRINE Injection, USPprescriptionHuman PrescriptionHospira, Inc.2014-05-051004097241
10ff31db75-1935-43df-9cd7-a63297d78cf5 (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 PrescriptionRemedyrepack Inc.2015-03-251617860242

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