Active ingredient
Nizatidine
7 finished FDA listings contain Nizatidine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- NIZATIDINE
- Dosage forms
- Capsule, Solution
- Routes
- Oral
- Manufacturers / labelers
- 4
- Strengths listed
- 15 mg/ml · 150 mg/1 · 300 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 42319
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 076178 | EPIC PHARMA LLC | 2002-07-05 | 2 |
| ANDA 075616 | WATSON LABS | 2002-07-09 | 2 |
| ANDA 077314 | DR REDDYS LABS LTD | 2005-09-15 | 2 |
| ANDA 090576 | AMNEAL PHARMS | 2009-11-18 | 1 |
Official labeling on DailyMed
- NIZATIDINE CAPSULE [EPIC PHARMA, LLC] · version 1 · 2025-01-06
- NIZATIDINE CAPSULE [ACTAVIS PHARMA, INC.] · version 9 · 2024-12-30
- NIZATIDINE SOLUTION [AMNEAL PHARMACEUTICALS LLC] · version 9 · 2024-10-25
- NIZATIDINE CAPSULE [DR REDDY'S LABORATORIES LIMITED] · version 3 · 2019-03-12
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.