Active ingredient
Prasterone
3 finished FDA listings contain Prasterone as their only active ingredient; 25 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- PRASTERONE
- Dosage forms
- Insert, Liquid
- Routes
- Oral, Vaginal
- Manufacturers / labelers
- 2
- Strengths listed
- 6 [hp_x]/ml · 6.5 mg/1
- Brand names in FDA listings
- Dhea, Intrarosa
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 3143
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 208470 | MILLICENT | 2016-11-16 | 2 |
Official labeling on DailyMed
- INTRAROSA (PRASTERONE) INSERT [MILLICENT US, INC.] · version 9 · 2026-08-03
- DHEA (DHEA (DEHYDROEPIANDROSTERONE)) LIQUID [DESERET BIOLOGICALS, INC.] · version 6 · 2024-09-25
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.