Active ingredient
Epinephrine
122 finished FDA listings contain Epinephrine as their only active ingredient; 257 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- EPINEPHRINE, EPINEPHRINE BITARTRATE, EPINEPHRINE HYDROCHLORIDE
- Dosage forms
- Aerosol, Injection, Injection, Solution, Injection, Solution, Concentrate, Liquid, Pellet, Solution, Spray
- Routes
- Dental, Intramuscular, Intraocular, Intravenous, Nasal, Oral, Periodontal, Respiratory (Inhalation), Subcutaneous, Subgingival
- Manufacturers / labelers
- 37
- Strengths listed
- .1 mg/.1ml · .1 mg/ml · .15 mg/.15ml · .15 mg/.3ml · .3 mg/.3ml · 1 mg/100ul · 1 mg/ml · 1200 mg/15ml · 125 ug/1 · 16 ug/ml · 2 mg/100ul · 20 ug/ml · 200 [kp_c]/200[kp_c] · 30 [hp_c]/30[hp_c] · 30 mg/30ml · 32 ug/ml · 40 ug/ml · 6 [hp_c]/6[hp_c] · 6 [hp_x]/ml · 64 ug/ml · 8 ug/ml · 9 [hp_x]/29.5ml
- Brand names in FDA listings
- Adrenalin, Adrenalin (Epinephrine In Sodium Chloride), Adrenalin Vials, Adrenalinum, Auvi-Q, Epinephrine, Epinephrine 1553, Epinephrine Pediatrics, Epipen, Epipen Jr, Neffy, Orostat 8%, Primatene Mist
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3992
Drugs@FDA applications
Linked only where the FDA listing’s application number matches Drugs@FDA exactly. A listing in the NDC Directory does not by itself mean FDA approval.
| Application | Sponsor | Original approval | Listings |
|---|---|---|---|
| NDA 019430 | VIATRIS | 1987-12-22 | 12 |
| NDA 020800 | IMPAX | 2003-05-30 | 14 |
| NDA 201739 | KALEO INC | 2012-08-10 | 16 |
| NDA 204200 | PH HEALTH | 2012-12-07 | 6 |
| NDA 204640 | PH HEALTH | 2013-12-18 | 4 |
| NDA 205029 | BPI LABS | 2014-07-29 | 13 |
| ANDA 207568 | AM REGENT | 2018-07-06 | 1 |
| ANDA 090589 | TEVA PHARMS USA | 2018-08-16 | 8 |
| NDA 205920 | ARMSTRONG PHARMS | 2018-11-07 | 2 |
| NDA 209359 | HOSPIRA | 2019-11-05 | 2 |
| ANDA 211880 | INTL MEDICATION SYS | 2020-04-24 | 1 |
| NDA 211363 | INTL MEDICATION SYS | 2022-08-15 | 7 |
| NDA 215875 | PH HEALTH | 2023-04-21 | 5 |
| NDA 214697 | ARS PHARMS OPERATION | 2024-08-09 | 5 |
| ANDA 217192 | AM REGENT | 2024-09-06 | 1 |
| ANDA 213708 | FRESENIUS KABI USA | 2024-11-20 | 2 |
| ANDA 219239 | GLAND | 2025-02-06 | 5 |
| NDA 218475 | BAXTER HLTHCARE CORP | 2025-02-28 | 2 |
| NDA 215425 | FRESENIUS KABI USA | 2025-03-13 | 2 |
| ANDA 218144 | GLAND | 2025-06-03 | 2 |
| ANDA 217485 | AMNEAL | 2025-10-14 | 1 |
| ANDA 218208 | AMNEAL | 2025-12-08 | 1 |
| NDA 220626 | BAXTER HLTHCARE CORP | 2026-03-30 | 2 |
| ANDA 220562 | HIKMA | 2026-05-29 | 2 |
Official labeling on DailyMed
- EPINEPHRINE INJECTION, SOLUTION, CONCENTRATE [REMEDYREPACK INC.] · version 3 · 2026-09-07
- EPINEPHRINE INJECTION [REMEDYREPACK INC.] · version 5 · 2026-08-31
- EPINEPHRINE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] · version 13 · 2026-08-21
- EPINEPHRINE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 2 · 2026-08-11
- EPINEPHRINE INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC] · version 2 · 2026-08-11
- EPINEPHRINE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 2 · 2026-08-05
- EPINEPHRINE INJECTION, SOLUTION, CONCENTRATE [FRESENIUS KABI USA, LLC] · version 2 · 2026-07-29
- EPINEPHRINE INJECTION [A-S MEDICATION SOLUTIONS] · version 6 · 2026-07-15
- EPINEPHRINE INJECTION, SOLUTION, CONCENTRATE [CIVICA, INC.] · version 2 · 2026-07-15
- ADRENALIN (EPINEPHRINE) INJECTION [PAR HEALTH USA, LLC] · version 24 · 2026-07-13
- EPINEPHRINE INJECTION, SOLUTION, CONCENTRATE [A-S MEDICATION SOLUTIONS] · version 15 · 2026-07-08
- OROSTAT 8% (EPINEPHRINE HYDROCHLORIDE) SOLUTION [GINGI-PAK A DIVISION OF THE BELPORT] · version 2 · 2026-06-29
Showing the 12 most recent of 92 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.