Active ingredient
Phenoxybenzamine
6 finished FDA listings contain Phenoxybenzamine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- PHENOXYBENZAMINE HYDROCHLORIDE
- Dosage forms
- Capsule
- Routes
- Oral
- Manufacturers / labelers
- 6
- Strengths listed
- 10 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 8149
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 |
|---|---|---|---|
| ANDA 212568 | AMNEAL | 2020-10-27 | 1 |
| ANDA 215042 | NOVITIUM PHARMA | 2022-07-19 | 1 |
| ANDA 215600 | AUROBINDO PHARMA | 2023-05-08 | 3 |
| ANDA 204551 | RISING | 2023-06-20 | 1 |
Official labeling on DailyMed
- PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [RISING PHARMA HOLDINGS, INC.] · version 1 · 2026-08-26
- PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [NORTHSTAR RX LLC] · version 3 · 2026-07-13
- PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC] · version 12 · 2026-07-06
- PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [BUREL PHARMACEUTICALS, LLC] · version 1 · 2025-01-10
- PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED] · version 2 · 2024-02-19
- PHENOXYBENZAMINE HYDROCHLORIDE CAPSULE [NOVITIUM PHARMA LLC] · version 2 · 2022-10-20
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.