Active ingredient
Lisdexamfetamine
178 finished FDA listings contain Lisdexamfetamine as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- LISDEXAMFETAMINE DIMESYLATE
- Dosage forms
- Capsule, Solution, Tablet, Chewable
- Routes
- Oral
- Manufacturers / labelers
- 21
- Strengths listed
- 10 mg/1 · 10 mg/ml · 20 mg/1 · 30 mg/1 · 40 mg/1 · 50 mg/1 · 60 mg/1 · 70 mg/1
- Brand names in FDA listings
- Arynta, Lisdexamfetamine Dimesylate, Vyvanse
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 700810
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 021977 | TAKEDA PHARMS USA | 2007-02-23 | 7 |
| NDA 208510 | TAKEDA PHARMS USA | 2017-01-28 | 6 |
| ANDA 202830 | AMNEAL | 2023-08-25 | 12 |
| ANDA 214547 | NORWICH | 2023-08-25 | 8 |
| ANDA 202802 | ACTAVIS ELIZABETH | 2023-08-25 | 7 |
| ANDA 211840 | SPECGX LLC | 2023-08-25 | 7 |
| ANDA 202827 | HIKMA | 2023-08-25 | 7 |
| ANDA 214484 | SUN PHARM INDS INC | 2023-08-25 | 7 |
| ANDA 215802 | LANNETT CO INC | 2023-08-25 | 7 |
| ANDA 216266 | PRINSTON INC | 2023-08-25 | 7 |
| ANDA 216944 | APOTEX | 2023-08-25 | 7 |
| ANDA 202835 | MYLAN | 2023-08-25 | 7 |
| ANDA 215330 | RHODES PHARMS | 2023-08-25 | 14 |
| ANDA 217442 | ASCENT PHARMS INC | 2023-08-25 | 13 |
| ANDA 215415 | TEVA PHARMS | 2023-08-25 | 6 |
| ANDA 214134 | SUN PHARM INDS INC | 2023-08-25 | 6 |
| ANDA 217068 | ASCENT PHARMS INC | 2023-08-25 | 6 |
| ANDA 218306 | MSN | 2024-02-02 | 6 |
| ANDA 202836 | SANDOZ | 2024-07-26 | 7 |
| ANDA 218604 | ELITE LABS INC | 2024-11-15 | 7 |
| ANDA 219258 | GRANULES | 2024-12-16 | 6 |
| ANDA 218850 | SPECGX LLC | 2024-12-17 | 6 |
| ANDA 218987 | GRANULES | 2025-01-29 | 7 |
| NDA 219847 | AZURITY | 2025-06-16 | 5 |
Official labeling on DailyMed
- LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE) CAPSULE [AMNEAL PHARMACEUTICALS LLC] · version 25 · 2026-09-10
- LISDEXAMFETAMINE DIMESYLATE CAPSULE [TEVA PHARMACEUTICALS, INC.] · version 6 · 2026-08-20
- LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE [TEVA PHARMACEUTICALS, INC.] · version 3 · 2026-08-03
- LISDEXAMFETAMINE DIMESYLATE CAPSULE LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE [SUN PHARMACEUTICAL INDUSTRIES, INC.] · version 9 · 2026-08-03
- LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE) CAPSULE [MYLAN PHARMACEUTICALS INC.] · version 5 · 2026-07-31
- LISDEXAMFETAMINE DIMESYLATE CAPSULE [BRYANT RANCH PREPACK] · version 103 · 2026-07-01
- LISDEXAMFETAMINE DIMESYLATE CAPSULE [ELITE LABORATORIES, INC.] · version 6 · 2026-06-26
- LISDEXAMFETAMINE DIMESYLATE CAPSULE [SANDOZ INC] · version 12 · 2026-06-25
- LISDEXAMFETAMINE DIMESYLATE CAPSULE [ALVOGEN INC.] · version 5 · 2026-06-23
- LISDEXAMFETAMINE DIMESYLATE CAPSULE [CAMBER PHARMACEUTICALS, INC.] · version 3 · 2026-06-15
- LISDEXAMFETAMINE DIMESYLATE TABLET, CHEWABLE [CAMBER PHARMACEUTICALS, INC.] · version 3 · 2026-06-15
- LISDEXAMFETAMINE DIMESYLATE (LISDEXAMFETAMINE DIMESYLATE CAPSULES) CAPSULE [SOLCO HEALTHCARE US,LLC] · version 8 · 2026-06-11
Showing the 12 most recent of 27 labels.
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.