NDC 70621-101

AMELUZ

Aminolevulinic Acid Hydrochloride

AMELUZ is a Topical Gel in the Human Prescription Drug category. It is labeled and distributed by Biofrontera Inc.. The primary component is Aminolevulinic Acid Hydrochloride.

Product ID70621-101_01a7d75b-33aa-457f-a21f-6fe53790b7e3
NDC70621-101
Product TypeHuman Prescription Drug
Proprietary NameAMELUZ
Generic NameAminolevulinic Acid Hydrochloride
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2016-08-26
Marketing CategoryNDA / NDA
Application NumberNDA208081
Labeler NameBiofrontera Inc.
Substance NameAMINOLEVULINIC ACID HYDROCHLORIDE
Active Ingredient Strength100 mg/g
Pharm ClassesPorphyrinogens [CS],Porphyrin Precursor [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70621-101-10

1 TUBE in 1 PACKAGE (70621-101-10) > 2 g in 1 TUBE (70621-101-01)
Marketing Start Date2017-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70621-101-10 [70621010110]

AMELUZ GEL
Marketing CategoryNDA
Application NumberNDA208081
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2017-06-01

NDC 70621-101-01 [70621010101]

AMELUZ GEL
Marketing CategoryNDA
Application NumberNDA208081
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2016-08-26
Marketing End Date2019-05-31

NDC 70621-101-30 [70621010130]

AMELUZ GEL
Marketing CategoryNDA
Application NumberNDA208081
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2017-06-01

Drug Details

Active Ingredients

IngredientStrength
AMINOLEVULINIC ACID HYDROCHLORIDE100 mg/g

OpenFDA Data

SPL SET ID:650daa9f-aeec-49ce-95b9-5fa20b988afd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1806650
  • 1806645

    • Pharmacological Class

    • Porphyrinogens [CS]
    • Porphyrin Precursor [EPC]

    NDC Crossover Matching brand name "AMELUZ" or generic name "Aminolevulinic Acid Hydrochloride"

    NDCBrand NameGeneric Name
    70621-101AMELUZaminolevulinic acid hydrochloride
    59137-231GLEOLANAMINOLEVULINIC ACID HYDROCHLORIDE
    71469-231GLEOLANAMINOLEVULINIC ACID HYDROCHLORIDE
    67308-101LEVULAN KERASTICKaminolevulinic acid hydrochloride

    Trademark Results [AMELUZ]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AMELUZ
    AMELUZ
    79079825 3956761 Live/Registered
    Biofrontera Pharma GmbH
    2009-12-23
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