Active ingredient
Nateglinide
18 finished FDA listings contain Nateglinide as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- NATEGLINIDE
- Dosage forms
- Tablet, Tablet, Coated, Tablet, Film Coated
- Routes
- Oral
- Manufacturers / labelers
- 9
- Strengths listed
- 120 mg/1 · 60 mg/1
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 274332
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 077463 | STRIDES PHARMA INTL | 2009-09-09 | 6 |
| ANDA 077461 | DR REDDYS LABS LTD | 2009-09-09 | 2 |
| ANDA 205248 | ZYDUS PHARMS | 2016-07-06 | 4 |
| ANDA 205544 | RISING | 2018-06-18 | 2 |
| ANDA 206432 | CADILA PHARMS LTD | 2019-04-19 | 4 |
Official labeling on DailyMed
- NATEGLINIDE TABLET [DR. REDDY'S LABORATORIES LIMITED] · version 11 · 2025-09-01
- NATEGLINIDE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] · version 2 · 2025-04-24
- NATEGLINIDE TABLET [STRIDES PHARMA SCIENCE LIMITED] · version 4 · 2025-02-26
- NATEGLINIDE TABLET [AMERICAN HEALTH PACKAGING] · version 5 · 2025-01-09
- NATEGLINIDE TABLET [RISING PHARMA HOLDINGS, INC.] · version 3 · 2024-12-11
- NATEGLINIDE TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED] · version 9 · 2024-12-06
- NATEGLINIDE TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.] · version 7 · 2023-11-10
- NATEGLINIDE TABLET, COATED [CADILA PHARMACEUTICALS LIMITED] · version 9 · 2022-12-29
- NATEGLINIDE TABLET, COATED [MODAVAR PHARMACEUTICALS LLC] · version 1 · 2022-03-14
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.