AMELUZ 100 mg/g
aminolevulinic acid hydrochloride · GEL · Biofrontera Inc.
No Recall History
Plain English
AMELUZ is a gel containing aminolevulinic acid hydrochloride at 100 mg/g, taken topical. Manufactured by Biofrontera Inc..
Key Facts
- Brand Name
- AMELUZ
- Generic Name
- aminolevulinic acid hydrochloride
- NDC Code (Product)
70621-101- Manufacturer
- Biofrontera Inc.
- Strength
- 100 mg/g
- Dosage Form
- GEL
- Route
- TOPICAL
- Marketing Status
- Application #
- NDA208081
- Marketing Start
- 08/26/2016
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
off label use74 reports
application site pain53 reports
application site erythema50 reports
hypotension26 reports
drug ineffective17 reports
application site swelling16 reports
pain12 reports
application site pustules10 reports
application site vesicles10 reports
erythema10 reports
Frequently Asked Questions
What is AMELUZ used for?
AMELUZ contains aminolevulinic acid hydrochloride. It is a gel taken topical. Consult your doctor for specific uses.
Is AMELUZ a controlled substance?
AMELUZ is not classified as a controlled substance by the DEA.
What is the generic name for AMELUZ?
The generic name for AMELUZ is aminolevulinic acid hydrochloride. There are 3 other brand versions of aminolevulinic acid hydrochloride.
What is the NDC code for AMELUZ 100 mg/g?
The NDC (National Drug Code) for AMELUZ 100 mg/g is 70621-101, listed by Biofrontera Inc..