Active ingredient
Nisoldipine
8 finished FDA listings contain Nisoldipine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- NISOLDIPINE
- Dosage forms
- Tablet, Film Coated, Extended Release
- Routes
- Oral
- Manufacturers / labelers
- 3
- Strengths listed
- 17 mg/1 · 34 mg/1 · 8.5 mg/1
- Brand names in FDA listings
- Sular
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 7435
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 020356 | AZURITY | 1995-02-02 | 6 |
| ANDA 216606 | AMTA | 2023-04-10 | 2 |
Official labeling on DailyMed
- NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.] · version 1 · 2026-08-03
- SULAR (NISOLDIPINE) TABLET, FILM COATED, EXTENDED RELEASE [COVIS PHARMA US, INC] · version 6 · 2026-04-09
- NISOLDIPINE TABLET, FILM COATED, EXTENDED RELEASE [PRASCO LABORATORIES] · version 21 · 2025-11-17
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.