Active ingredient
Dronabinol
18 finished FDA listings contain Dronabinol as their only active ingredient.
FDA NDC Directory
- Ingredient names as written by FDA
- DRONABINOL
- Dosage forms
- Capsule, Solution
- Routes
- Oral
- Manufacturers / labelers
- 7
- Strengths listed
- 10 mg/1 · 2.5 mg/1 · 5 mg/1 · 5 mg/ml
- Brand names in FDA listings
- Marinol, Syndros
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 10402
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 018651 | ALKEM LABS LTD | 1985-05-31 | 11 |
| NDA 205525 | WELLHOUSE PHARMA | 2016-07-01 | 4 |
| ANDA 207421 | ASCENT PHARMS INC | 2020-02-07 | 3 |
Official labeling on DailyMed
- DRONABINOL CAPSULE [MAJOR PHARMACEUTICALS] · version 6 · 2026-05-21
- DRONABINOL CAPSULE [ASCEND LABORATORIES, LLC] · version 5 · 2026-05-11
- SYNDROS (DRONABINOL) SOLUTION [BENUVIA OPERATIONS, LLC] · version 9 · 2026-04-27
- SYNDROS (DRONABINOL) SOLUTION [WELLHOUSE PHARMA, LLC] · version 1 · 2026-04-22
- DRONABINOL CAPSULE [CAMBER PHARMACEUTICALS INC] · version 4 · 2026-04-17
- DRONABINOL SOLUTION [WELLHOUSE PHARMA, LLC] · version 1 · 2026-02-16
- DRONABINOL SOLUTION [CHARTWELL RX, LLC] · version 1 · 2026-01-28
- MARINOL (DRONABINOL) CAPSULE [THEPHARMANETWORK, LLC] · version 5 · 2023-02-15
- MARINOL (DRONABINOL) CAPSULE [THEPHARMANETWORK, LLC] · version 1 · 2020-04-13
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.