Active ingredient
Norepinephrine
45 finished FDA listings contain Norepinephrine as their only active ingredient; 12 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- NORADRENALINE HYDROCHLORIDE, NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE
- Dosage forms
- Injection, Injection, Solution, Injection, Solution, Concentrate, Liquid, Solution
- Routes
- Intravenous, Oral
- Manufacturers / labelers
- 29
- Strengths listed
- .016 mg/ml · .032 mg/ml · .064 mg/ml · .128 mg/ml · 1 mg/ml · 16 mg/250ml · 16 ug/ml · 32 ug/ml · 4 mg/250ml · 6 [hp_x]/ml · 64 ug/ml · 8 [hp_x]/ml · 8 mg/250ml · 9 [hp_x]/29.5ml
- Brand names in FDA listings
- Levophed, Norepinephrine, Norepinephrine 1530, Norepinephrine Bitartrate In Sodium Chloride, Norepinephrine Phenolic
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7512
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 007513 | HOSPIRA | 1950-07-13 | 3 |
| ANDA 040455 | MEITHEAL | 2003-03-03 | 1 |
| ANDA 211242 | MYLAN LABS LTD | 2018-10-04 | 2 |
| ANDA 211359 | SANDOZ | 2018-10-18 | 2 |
| ANDA 203662 | HIKMA | 2018-11-07 | 2 |
| ANDA 211382 | FRESENIUS KABI USA | 2020-11-03 | 2 |
| NDA 214313 | BAXTER HLTHCARE CORP | 2021-01-15 | 6 |
| ANDA 214455 | BRECKENRIDGE | 2021-01-22 | 1 |
| ANDA 211980 | SUN PHARM | 2021-01-29 | 1 |
| ANDA 214323 | GLAND | 2021-05-06 | 3 |
| NDA 215700 | INFORLIFE | 2022-09-15 | 4 |
| NDA 214628 | LONG GROVE PHARMS | 2022-10-06 | 3 |
| ANDA 217575 | CAPLIN | 2023-09-15 | 3 |
| ANDA 218758 | RISING | 2024-05-13 | 1 |
| ANDA 219163 | ASPIRO | 2025-01-31 | 1 |
| ANDA 219443 | BIOCON PHARMA | 2025-03-21 | 1 |
| ANDA 219924 | ADAPTIS | 2025-11-25 | 2 |
| ANDA 218595 | MSN | 2025-12-11 | 1 |
Official labeling on DailyMed
- NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [BRECKENRIDGE PHARMACEUTICAL, INC.] · version 4 · 2026-09-02
- NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [SANDOZ INC] · version 11 · 2026-08-20
- NOREPINEPHRINE BITARTRATE INJECTION [BAXTER HEALTHCARE COMPANY] · version 6 · 2026-07-24
- NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [MYLAN INSTITUTIONAL LLC] · version 4 · 2026-06-23
- NOREPINEPHRINE BITARTRATE INJECTION [HF ACQUISITION CO LLC, DBA HEALTHFIRST] · version 4 · 2026-06-22
- NOREPINEPHRINE BITARTRATE IN SODIUM CHLORIDE (NOREPINEPHRINE BITARTRATE) INJECTION, SOLUTION [WG CRITICAL CARE, LLC] · version 10 · 2026-02-18
- NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION] · version 13 · 2026-02-16
- NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION [AVENACY, LLC] · version 1 · 2026-02-02
- NOREPINEPHRINE 1530 (NOREPINEPHRINE) LIQUID [PROFESSIONAL COMPLEMENTARY HEALTH FORMULAS] · version 2 · 2026-01-12
- NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [NOVADOZ PHARMACEUTICALS LLC] · version 1 · 2025-12-19
- NOREPINEPHRINE (NOREPINEPHRINE BITARTRATE) SOLUTION [LONG GROVE PHARMACEUTICALS, LLC] · version 2 · 2025-12-10
- NOREPINEPHRINE BITARTRATE INJECTION, SOLUTION, CONCENTRATE [ANTHEA PHARMA PRIVATE LIMITED] · version 3 · 2025-11-27
Showing the 12 most recent of 35 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.