Active ingredient
Phentermine
122 finished FDA listings contain Phentermine as their only active ingredient; 16 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- PHENTERMINE, PHENTERMINE HYDROCHLORIDE
- Dosage forms
- Capsule, Tablet
- Routes
- Oral
- Manufacturers / labelers
- 27
- Strengths listed
- 15 mg/1 · 30 mg/1 · 37.5 mg/1 · 8 mg/1
- Brand names in FDA listings
- Lomaira, Phentermine, Phentermine Hcl
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 8152
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 083923 | CHARTWELL RX | 1976-07-01 | 1 |
| ANDA 040190 | ELITE LABS INC | 1997-05-30 | 2 |
| ANDA 040228 | ELITE LABS INC | 1997-06-19 | 1 |
| ANDA 040377 | PRINSTON INC | 2002-01-04 | 1 |
| ANDA 040526 | SUN PHARM INDUSTRIES | 2003-10-23 | 16 |
| ANDA 040875 | KVK TECH | 2008-03-21 | 7 |
| ANDA 040886 | KVK TECH | 2008-03-31 | 12 |
| ANDA 040876 | KVK TECH | 2008-03-31 | 9 |
| ANDA 040887 | KVK TECH | 2008-04-24 | 4 |
| ANDA 200272 | ELITE LABS | 2011-01-31 | 10 |
| ANDA 202248 | ELITE LABS | 2012-09-28 | 10 |
| ANDA 203068 | AUROBINDO PHARMA LTD | 2014-08-06 | 3 |
| ANDA 205008 | NUVO PHARM | 2014-09-25 | 11 |
| ANDA 205017 | NUVO PHARM | 2014-09-25 | 6 |
| ANDA 205019 | NUVO PHARM | 2014-12-05 | 24 |
| ANDA 203495 | AVANTHI INC | 2016-09-12 | 2 |
| ANDA 204318 | AUROLIFE PHARMA LLC | 2016-11-09 | 2 |
| ANDA 203436 | KVK TECH INC | 2017-03-17 | 1 |
Official labeling on DailyMed
- PHENTERMINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS INC.] · version 7 · 2026-08-19
- PHENTERMINE HYDROCHLORIDE CAPSULE [PREFERRED PHARMACEUTICALS, INC.] · version 8 · 2026-08-19
- PHENTERMINE HYDROCHLORIDE TABLET [PREFERRED PHARMACEUTICALS INC.] · version 6 · 2026-08-19
- PHENTERMINE HYDROCHLORIDE TABLET [NORTHWIND HEALTH COMPANY, LLC] · version 1 · 2026-07-31
- PHENTERMINE HYDROCHLORIDE TABLET [NORTHWIND HEALTH COMPANY, LLC] · version 2 · 2026-07-22
- PHENTERMINE HYDROCHLORIDE TABLET [AUROLIFE PHARMA LLC] · version 8 · 2026-06-15
- PHENTERMINE HYDROCHLORIDE TABLET [PD-RX PHARMACEUTICALS, INC.] · version 14 · 2026-06-03
- PHENTERMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] · version 2 · 2026-06-03
- LOMAIRA (PHENTERMINE HYDROCHLORIDE) TABLET [CALVIN SCOTT & CO., INC.] · version 3 · 2026-06-01
- PHENTERMINE HYDROCHLORIDE TABLET [CALVIN SCOTT & CO., INC.] · version 3 · 2026-06-01
- PHENTERMINE (PHENTERMINE HYDROCHLORIDE) CAPSULE [CALVIN SCOTT & CO., INC.] · version 4 · 2026-06-01
- PHENTERMINE HYDROCHLORIDE CAPSULE [CALVIN SCOTT & CO., INC.] · version 2 · 2026-06-01
Showing the 12 most recent of 111 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.