FDA — authorised 3 March 2003
- Application: ANDA040455
- Marketing authorisation holder: MEITHEAL
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 NOREPINEPHRINE BITARTRATE in United States
FDA authorised NOREPINEPHRINE BITARTRATE on 3 March 2003 · 2,314 US adverse-event reports
Marketing authorisations
FDA — authorised 30 September 2004
- Application: ANDA040522
- Marketing authorisation holder: METRICS PHARM
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 27 March 2012
- Application: ANDA040859
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 4 October 2018
- Application: ANDA211242
- Marketing authorisation holder: MYLAN LABS LTD
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 18 October 2018
- Application: ANDA211359
- Marketing authorisation holder: SANDOZ
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 7 November 2018
- Application: ANDA203662
- Marketing authorisation holder: HIKMA
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 17 December 2018
- Application: ANDA210839
- Marketing authorisation holder: AMNEAL
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 3 November 2020
- Application: ANDA211382
- Marketing authorisation holder: FRESENIUS KABI USA
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 January 2021
- Application: NDA214313
- Marketing authorisation holder: BAXTER HLTHCARE CORP
- Local brand name: NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 22 January 2021
- Application: ANDA214455
- Marketing authorisation holder: BRECKENRIDGE
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 29 January 2021
- Application: ANDA211980
- Marketing authorisation holder: SUN PHARM
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 6 May 2021
- Application: ANDA214323
- Marketing authorisation holder: GLAND
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 19 July 2022
- Application: ANDA216341
- Marketing authorisation holder: ZYDUS PHARMS
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 15 September 2022
- Application: NDA215700
- Marketing authorisation holder: INFORLIFE
- Local brand name: NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 6 October 2022
- Application: NDA214628
- Marketing authorisation holder: LONG GROVE PHARMS
- Local brand name: NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE
- Indication: SOLUTION — INTRAVENOUS
- Status: approved
FDA — authorised 15 September 2023
- Application: ANDA217575
- Marketing authorisation holder: CAPLIN
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 13 May 2024
- Application: ANDA218758
- Marketing authorisation holder: RISING
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 31 January 2025
- Application: ANDA219163
- Marketing authorisation holder: ASPIRO
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 21 March 2025
- Application: ANDA219443
- Marketing authorisation holder: BIOCON PHARMA
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 25 November 2025
- Application: ANDA219924
- Marketing authorisation holder: ANTHEA PHARMA
- Local brand name: NOREPINEPHRINE BITARTRATE
- Indication: INJECTABLE — INJECTION
- Status: approved
FDA — authorised 11 December 2025
- Application: ANDA218595
- Marketing authorisation holder: MSN
- Status: approved
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 20 April 2025 – 20 April 2026
- Total reports: 2,314
Most-reported reactions
- Drug Ineffective — 371 reports (16.03%)
- Hypotension — 280 reports (12.1%)
- Condition Aggravated — 272 reports (11.75%)
- Off Label Use — 232 reports (10.03%)
- Sepsis — 226 reports (9.77%)
- Multiple Organ Dysfunction Syndrome — 210 reports (9.08%)
- Cardiogenic Shock — 201 reports (8.69%)
- Stress — 188 reports (8.12%)
- Renal Failure — 167 reports (7.22%)
- Vomiting — 167 reports (7.22%)
NOREPINEPHRINE BITARTRATE in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is NOREPINEPHRINE BITARTRATE approved in United States?
Yes. FDA authorised it on 3 March 2003; FDA authorised it on 30 September 2004; FDA authorised it on 27 March 2012.
Who is the marketing authorisation holder for NOREPINEPHRINE BITARTRATE in United States?
MEITHEAL holds the US marketing authorisation.