Epinephrine Prefilled Syringe

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2012-08-30)
Oldest Current Product
1976-12-01
License(s)
NDA, UNAPPROVED DRUG OTHER MARKETING CATEGORY
RxNORM
PREFILLED SYRINGE\EPINEPHRINE
FDAOB
INTRAMUSCULAR, SUBCUTANEOUS\INJECTION\EPINEPHRINE\rdfq
INTRAMUSCULAR\INJECTION\EPINEPHRINE
SPL Active
ENDOTRACHEAL\INJECTION, SOLUTION\EPINEPHRINE
INTRACARDIAC\INJECTION, SOLUTION\EPINEPHRINE
INTRAVENOUS\INJECTION, SOLUTION\EPINEPHRINE
PARENTERAL\INJECTION\EPINEPHRINE
SPL Moiety
ENDOTRACHEAL\INJECTION, SOLUTION\EPINEPHRINE
INTRACARDIAC\INJECTION, SOLUTION\EPINEPHRINE
INTRAVENOUS\INJECTION, SOLUTION\EPINEPHRINE
PARENTERAL\INJECTION\EPINEPHRINE

product(s) by strength(s)

10 ml epinephrine 0.1 mg/ml prefilled syringe

original product(s)(s)

#idcategorylabelerfirst marketedlast marketedactive ingredient(s)routedose formspl
1004094901UNAPPROVED DRUG OTHER MARKETING CATEGORYHospira, Inc.1985-05-01EPINEPHRINEENDOTRACHEALINJECTION, SOLUTIONa01c237d-ae30-4326-9731-fde72505a4a6
2004094921UNAPPROVED DRUG OTHER MARKETING CATEGORYHospira, Inc.1985-04-05EPINEPHRINEENDOTRACHEALINJECTION, SOLUTIONa01c237d-ae30-4326-9731-fde72505a4a6
3005481016UNAPPROVED DRUG OTHER MARKETING CATEGORYAmphastar Pharmaceuticals, Inc.1976-12-012009-12-31EPINEPHRINEPARENTERALINJECTION94d7b0e6-d7fd-449a-ada9-7a765a3d233b

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840001UNAPPROVED DRUG OTHER MARKETING CATEGORYGeneral Injecatables & Vaccines, Inc2010-08-01EPINEPHRINEINTRAVENOUSINJECTION, SOLUTION004094901de6a969a-7e0f-4e5f-8d12-de5c7129d39c
2525840004NDAGeneral Injecatables & Vaccines, Inc2010-08-01EPINEPHRINEINTRAVENOUSINJECTION, SOLUTION004094921NDA020800a41b3e0c-8f43-49a5-90ea-0509e5fc18e2
3548685725NDAPhysicians Total Care, Inc.2006-12-11EPINEPHRINEINTRACARDIACINJECTION, SOLUTION00409492134NDA020800da3009a0-9eed-4254-90f9-b4b024073828
4551543186UNAPPROVED DRUG OTHER MARKETING CATEGORYCardinal Health1985-04-05EPINEPHRINEENDOTRACHEALINJECTION, SOLUTION004094921e609bab7-c671-424d-bd9d-ced0affa0b4d
5551543195UNAPPROVED DRUG OTHER MARKETING CATEGORYCardinal Health1985-05-01EPINEPHRINEENDOTRACHEALINJECTION, SOLUTION004094901e609bab7-c671-424d-bd9d-ced0affa0b4d
6637390456NDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2010-05-03EPINEPHRINEINTRACARDIACINJECTION, SOLUTION004094921NDA0208003af22732-ff86-4ae2-813a-d2bcf0924471

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 Injectable Solution
2NDA020800ADRENACLICKAMEDRA PHARMACEUTICALS LLC2003-05-30p7297136, SUBSTANCE
p7621891, SUBSTANCE
NDA020800_001, NDA020800_002, NDA020800_003, NDA020800_004Epinephrine Auto-Injector
Epinephrine Injection
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 Injection
Epinephrine Injectable Solution
4NDA204640ADRENALINPAR STERILE PRODUCTS LLC2013-12-18p9119876, SUBSTANCENDA204640_001Epinephrine Auto-Injector
Epinephrine Injection
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 Auto-Injector
Epinephrine Injection
Epinephrine Injectable Solution
2p7449012 (view patent)2025-09-11NDA019430Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Injectable Solution
3p7621891 (view patent)2025-02-04NDA020800Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Injectable Solution
4p7731686 (view patent)2026-06-01NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Naloxone Auto-Injector
Epinephrine Injectable Solution
5p7731690 (view patent)2025-01-15NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Naloxone Auto-Injector
Epinephrine Injectable Solution
6p7749194 (view patent)2028-10-30NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Naloxone Auto-Injector
Epinephrine Injectable Solution
7p7794432 (view patent)2025-09-11NDA019430Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Injectable Solution
8p7918823 (view patent)2024-11-23NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Naloxone Auto-Injector
Epinephrine Injectable Solution
9p7947017 (view patent)2028-03-12NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Naloxone Auto-Injector
Epinephrine Injectable Solution
10p8016788 (view patent)2025-03-21NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Naloxone Auto-Injector
Epinephrine Injectable Solution
11p8021344 (view patent)2029-11-02NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Naloxone Auto-Injector
Epinephrine Injectable Solution
12p8048035 (view patent)2025-09-11NDA019430Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Injectable Solution
13p8206360 (view patent)2027-02-27NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Naloxone Auto-Injector
Epinephrine Injectable Solution
14p8226610 (view patent)2029-04-10NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Naloxone Auto-Injector
Epinephrine Injectable Solution
15p8231573 (view patent)2028-11-25NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Naloxone Auto-Injector
Epinephrine Injectable Solution
16p8313466 (view patent)2024-11-23NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Naloxone Auto-Injector
Epinephrine Injectable Solution
17p8361029 (view patent)2024-11-23NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Naloxone Auto-Injector
Epinephrine Injectable Solution
18p8425462 (view patent)2024-11-23NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Naloxone Auto-Injector
Epinephrine Injectable Solution
19p8608698 (view patent)2024-11-23NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Naloxone Auto-Injector
Epinephrine Injectable Solution
20p8870827 (view patent)2025-09-11NDA019430Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Injectable Solution
21p8920377 (view patent)2024-11-23NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Injectable Solution
22p8926594 (view patent)2026-03-31NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Naloxone Auto-Injector
Epinephrine Injectable Solution
23p9056170 (view patent)2024-11-23NDA201739, NDA205787Epinephrine Auto-Injector
Epinephrine Injection
Naloxone Auto-Injector
Epinephrine Injectable Solution
24p9119876 (view patent)2035-03-13NDA204640Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Injectable Solution
25p9149579 (view patent)2025-07-19NDA201739Epinephrine Auto-Injector
Epinephrine Injection
Epinephrine Injectable Solution

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1353f2d30-4b74-43eb-a2ff-26d593d283f8 (view SPL)prescriptionHuman PrescriptionInternational Medication Systems, Limitedanalysis, label, manufacture2015-05-113763293316
23af22732-ff86-4ae2-813a-d2bcf0924471 (view SPL)Epinephrine Injection, USP1:10,0001 mg (0.1 mg/mL)Abboject SyringeprescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationMANUFACTURE, REPACK2010-05-031637390456
394d7b0e6-d7fd-449a-ada9-7a765a3d233b (view SPL)EPINEPHRINE INJECTION, USPprescriptionHuman PrescriptionAmphastar Pharmaceuticals, Inc.2010-09-023005481016, 005482016, 005483316
4a01c237d-ae30-4326-9731-fde72505a4a6 (view SPL)EPINEPHRINEInjection, USPprescriptionHuman PrescriptionHospira, Inc.2012-08-301004094901, 004094921
5a41b3e0c-8f43-49a5-90ea-0509e5fc18e2 (view SPL)Epinephrine 1:10,000 0.1 mg/mL Injection, USP 10 mL PreFilled SyringeprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-08-101525840004
6da3009a0-9eed-4254-90f9-b4b024073828 (view SPL)Epinephrine Injection, USP1:10,0001 mg (0.1 mg/mL)Abboject SyringeprescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel2010-05-031548685725
7de6a969a-7e0f-4e5f-8d12-de5c7129d39c (view SPL)Epinephrine 1:10,000 0.1 mg/mL Injection, USP 10 mL PreFilled SyringeprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2013-03-072525840001
8e609bab7-c671-424d-bd9d-ced0affa0b4d (view SPL)EPINEPHRINEInjection, USPprescriptionHuman PrescriptionCardinal HealthREPACK2015-01-262551543186, 551543195

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