NDC 59137-231

GLEOLAN

Aminolevulinic Acid Hydrochloride

GLEOLAN is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Medexus Pharma, Inc.. The primary component is Aminolevulinic Acid Hydrochloride.

• Product ID: 59137-231_1e70e08b-337c-42d5-9b37-5c8f6fbcce7e
• NDC: 59137-231
• Product Type: Human Prescription Drug
• Proprietary Name: GLEOLAN
• Generic Name: Aminolevulinic Acid Hydrochloride
• Dosage Form: Powder, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 2018-04-14
• Marketing Category: NDA /
• Application Number: NDA208630
• Labeler Name: Medexus Pharma, Inc.
• Substance Name: AMINOLEVULINIC ACID HYDROCHLORIDE
• Active Ingredient Strength: 1500 mg/1
• Pharm Classes: Fluorescence Contrast Activity [MoA], Optical Imaging Agent [EPC], Porphyrin Precursor [EPC], Porphyrinogens [CS]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 59137-231-01

1 VIAL, SINGLE-DOSE in 1 CARTON (59137-231-01) > 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2022-03-01
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details

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

NDC	Brand Name	Generic Name
59137-231	GLEOLAN	AMINOLEVULINIC ACID HYDROCHLORIDE
71469-231	GLEOLAN	AMINOLEVULINIC ACID HYDROCHLORIDE
70621-101	AMELUZ	aminolevulinic acid hydrochloride
67308-101	LEVULAN KERASTICK	aminolevulinic acid hydrochloride