Active ingredient
Betaine
4 finished FDA listings contain Betaine as their only active ingredient; 12 combination products also contain it.
FDA NDC Directory
- Ingredient names as written by FDA
- BETAINE, BETAINE HYDROCHLORIDE
- Dosage forms
- Liquid, Powder, For Solution
- Routes
- Oral, Topical
- Manufacturers / labelers
- 4
- Strengths listed
- .001 g/100ml · 1 g/g
- Brand names in FDA listings
- Cystadane, Dr.jucre Rebirth Activating Toner
RxNorm (National Library of Medicine)
Ingredient concept RxCUI 1512
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 020576 | RECORDATI RARE | 1996-10-25 | 1 |
| ANDA 214864 | NOVITIUM PHARMA | 2021-11-23 | 1 |
| ANDA 210508 | ETON | 2022-01-28 | 1 |
Official labeling on DailyMed
- BETAINE POWDER, FOR SOLUTION [COSETTE PHARMACEUTICALS, INC.] · version 3 · 2026-05-21
- CYSTADANE (BETAINE) POWDER, FOR SOLUTION [RECORDATI RARE DISEASES] · version 7 · 2026-04-27
- BETAINE ANHYDROUS POWDER, FOR SOLUTION [ETON PHARMACEUTICALS, INC.] · version 7 · 2025-11-17
- DR.JUCRE REBIRTH ACTIVATING TONER (BETAINE) LIQUID [NATURECELL CO., LTD.] · version 1 · 2022-11-08
Sources: FDA NDC Directory (2026-09-29), RxNorm, Drugs@FDA, DailyMed. Each source’s facts are shown separately as published.