Active ingredient
Droxidopa
45 finished FDA listings contain Droxidopa as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DROXIDOPA
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 15
- Strengths listed
- 100 mg/1 · 100 ug/1 · 200 mg/1 · 200 ug/1 · 300 mg/1 · 300 ug/1
- Brand names in FDA listings
- Northera
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1489913
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 203202 | LUNDBECK NA LTD | 2014-02-18 | 3 |
| ANDA 211818 | ZYDUS PHARMS | 2021-02-18 | 6 |
| ANDA 211741 | MSN PHARMS INC | 2021-02-18 | 6 |
| ANDA 213911 | ALKEM LABS LTD | 2021-02-18 | 6 |
| ANDA 214384 | SUN PHARM | 2021-02-18 | 3 |
| ANDA 214387 | AUROBINDO PHARMA LTD | 2021-02-18 | 3 |
| ANDA 214017 | SCIEGEN PHARMS | 2021-02-18 | 6 |
| ANDA 211652 | LUPIN PHARMS | 2021-02-18 | 3 |
| ANDA 211726 | ANNORA | 2021-02-18 | 3 |
| ANDA 213033 | BIONPHARMA | 2021-04-28 | 3 |
| ANDA 215265 | ADAPTIS | 2021-11-01 | 3 |
Official labeling on DailyMed
- DROXIDOPA CAPSULE [NOVADOZ PHARMACEUTICALS LLC] · version 2 · 2026-02-10
- NORTHERA (DROXIDOPA) CAPSULE [LUNDBECK PHARMACEUTICALS LLC] · version 26 · 2025-12-17
- DROXIDOPA CAPSULE [ASCEND LABORATORIES, LLC] · version 5 · 2025-07-24
- DROXIDOPA CAPSULE [CIVICASCRIPT LLC] · version 1 · 2025-03-04
- DROXIDOPA CAPSULE [ZYDUS LIFESCIENCES LIMITED] · version 3 · 2024-12-02
- DROXIDOPA CAPSULE [MAJOR PHARMACEUTICALS] · version 2 · 2024-01-29
- DROXIDOPA CAPSULE [LUPIN PHARMACEUTICALS, INC.] · version 6 · 2023-12-20
- DROXIDOPA CAPSULE [ZYDUS PHARMACEUTICALS USA INC.] · version 2 · 2023-09-21
- DROXIDOPA CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 1 · 2023-06-16
- DROXIDOPA CAPSULE [SLATE RUN PHARMACEUTICALS, LLC] · version 2 · 2023-03-30
- DROXIDOPA CAPSULE [BIONPHARMA INC.] · version 1 · 2021-10-04
- DROXIDOPA (DROXIDOPA) CAPSULE [CAMBER PHARMACEUTICALS, INC.] · version 2 · 2021-08-18
Showing the 12 most recent of 15 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.