NDC 71469-231

GLEOLAN

Aminolevulinic Acid Hydrochloride

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

• Product ID: 71469-231_1be997f9-81a5-448c-b0fe-5b114b2b152e
• NDC: 71469-231
• 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: 2018-03-14
• Marketing Category: NDA / NDA
• Application Number: NDA208630
• Labeler Name: NX DEVELOPMENT CORP
• Substance Name: AMINOLEVULINIC ACID HYDROCHLORIDE
• Active Ingredient Strength: 1500 mg/1
• Pharm Classes: Porphyrinogens [CS],Porphyrin Precursor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 71469-231-01

1 VIAL, SINGLE-DOSE in 1 CARTON (71469-231-01) > 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2018-03-14
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 71469-231-01 [71469023101]

GLEOLAN POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA208630
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-03-14

Drug Details

Active Ingredients

Ingredient	Strength
AMINOLEVULINIC ACID HYDROCHLORIDE	1500 mg/1

OpenFDA Data

• SPL SET ID: cdeded66-0017-42cf-9471-13f231014323
• Manufacturer:
  • NX DEVELOPMENT CORP
• UNII:
  • V35KBM8JGR

Pharmacological Class

• Porphyrinogens [CS]
• Porphyrin Precursor [EPC]
• Porphyrinogens [CS]
• Porphyrin Precursor [EPC]

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