FDA Orange Book · active-ingredient family
Norepinephrine bitartrate
Norepinephrine bitartrate is approved as 4 brand and 22 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE · NDA 214313
4
Brand (NDA)
22
Generics (ANDA)
12
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDERLD×6 | BAXTER HLTHCARE CORP | NDA 214313 | — | Feb 06, 2026 | |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDERLD×3 | LONG GROVE PHARMS | NDA 214628 | — | Oct 06, 2022 | |
| NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDERLD×4 | INFORLIFE | NDA 215700 | — | Sep 15, 2022 | |
| LEVOPHEDRLD | HOSPIRA | NDA 007513 | AP | Approved Prior to Jan 1, 1982 |
Generic (ANDA) products (22)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NOREPINEPHRINE BITARTRATE | NEPHRON | ANDA 216272 | AP | Jun 11, 2026 | |
| NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE | SAGENT | ANDA 220483 | AP | Mar 26, 2026 | |
| NOREPINEPHRINE BITARTRATE | MSN | ANDA 218595 | AP | Dec 11, 2025 | |
| NOREPINEPHRINE BITARTRATE | ANTHEA PHARMA | ANDA 219924 | AP | Nov 25, 2025 | |
| NOREPINEPHRINE BITARTRATE IN 5% DEXTROSE×2 | SAGENT | ANDA 219692 | AP | Aug 11, 2025 | |
| NOREPINEPHRINE BITARTRATE | BIOCON PHARMA | ANDA 219443 | AP | Mar 21, 2025 | |
| NOREPINEPHRINE BITARTRATE | ASPIRO | ANDA 219163 | AP | Jan 31, 2025 | |
| NOREPINEPHRINE BITARTRATE | RISING | ANDA 218758 | AP | May 13, 2024 | |
| NOREPINEPHRINE BITARTRATE | CAPLIN | ANDA 217575 | AP | Sep 15, 2023 | |
| NOREPINEPHRINE BITARTRATE | ZYDUS PHARMS | ANDA 216341 | — | Jul 19, 2022 | |
| NOREPINEPHRINE BITARTRATE | GLAND | ANDA 214323 | AP | May 06, 2021 | |
| NOREPINEPHRINE BITARTRATE | SUN PHARM | ANDA 211980 | — | Jan 29, 2021 | |
| NOREPINEPHRINE BITARTRATE | BRECKENRIDGE | ANDA 214455 | AP | Jan 22, 2021 | |
| NOREPINEPHRINE BITARTRATE | FRESENIUS KABI USA | ANDA 211382 | AP | Nov 03, 2020 | |
| NOREPINEPHRINE BITARTRATE | AMNEAL | ANDA 210839 | AP | Dec 17, 2018 | |
| NOREPINEPHRINE BITARTRATE | HIKMA | ANDA 203662 | AP | Nov 07, 2018 | |
| NOREPINEPHRINE BITARTRATE | SANDOZ | ANDA 211359 | AP | Oct 18, 2018 | |
| NOREPINEPHRINE BITARTRATE | MYLAN LABS LTD | ANDA 211242 | AP | Oct 04, 2018 | |
| NOREPINEPHRINE BITARTRATE | BAXTER HLTHCARE CORP | ANDA 040859 | AP | Mar 27, 2012 | |
| NOREPINEPHRINE BITARTRATE | METRICS PHARM | ANDA 040522 | — | Sep 30, 2004 | |
| NOREPINEPHRINE BITARTRATE | HIKMA | ANDA 040462 | AP | Oct 31, 2003 | |
| NOREPINEPHRINE BITARTRATE | MEITHEAL | ANDA 040455 | AP | Mar 03, 2003 |
Listed patents (12)
| Patent | Expires | In | Type |
|---|---|---|---|
| RE49422 | Feb 26, 2035 | in 8 yr 10 mo | Product |
| RE49443 | Feb 26, 2035 | in 8 yr 10 mo | Product |
| 11413259 | Jan 30, 2038 | in 11 yr 9 mo | ProductU-3461 |
| 10420735 | Jan 30, 2038 | in 11 yr 9 mo | ProductU-3461 |
| 10226436 | Jan 30, 2038 | in 11 yr 9 mo | ProductU-3461 |
| 12245996 | Jan 30, 2038 | in 11 yr 9 mo | Product |
| 10568850 | Jan 30, 2038 | in 11 yr 9 mo | Product |
| 10159657 | Jan 30, 2038 | in 11 yr 9 mo | Product |
| 11602508 | Jan 30, 2038 | in 11 yr 9 mo | Product |
| 10888534 | Apr 26, 2039 | in 13 yr | Product |
| 12097170 | Mar 08, 2041 | in 14 yr 11 mo | ProductU-3995 |
| 12290494 | Mar 08, 2041 | in 14 yr 11 mo | Product |
Norepinephrine bitartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
