gleolan

Generic: aminolevulinic acid hydrochloride

Labeler: medexus pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gleolan
Generic Name aminolevulinic acid hydrochloride
Labeler medexus pharma, inc.
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

aminolevulinic acid hydrochloride 1500 mg/1

Manufacturer
Medexus Pharma, Inc.

Identifiers & Regulatory

Product NDC 59137-231
Product ID 59137-231_425c0da5-cec7-4a38-88ee-b230c0601f51
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208630
Listing Expiration 2026-12-31
Marketing Start 2018-04-14

Pharmacologic Class

Classes
fluorescence contrast activity [moa] optical imaging agent [epc] porphyrin precursor [epc] porphyrinogens [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59137231
Hyphenated Format 59137-231

Supplemental Identifiers

UPC
0359137231017
UNII
V35KBM8JGR

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name gleolan (source: ndc)
Generic Name aminolevulinic acid hydrochloride (source: ndc)
Application Number NDA208630 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1500 mg/1
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (59137-231-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

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

Ingredients (1)

aminolevulinic acid hydrochloride (1500 mg/1)

Linked Drug Pages (1)

GLEOLAN ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "425c0da5-cec7-4a38-88ee-b230c0601f51", "openfda": {"upc": ["0359137231017"], "unii": ["V35KBM8JGR"], "spl_set_id": ["4873911e-a5d7-47e3-9679-fa5c95999323"], "manufacturer_name": ["Medexus Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (59137-231-01)  / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "59137-231-01", "marketing_start_date": "20220301"}], "brand_name": "GLEOLAN", "product_id": "59137-231_425c0da5-cec7-4a38-88ee-b230c0601f51", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Fluorescence Contrast Activity [MoA]", "Optical Imaging Agent [EPC]", "Porphyrin Precursor [EPC]", "Porphyrinogens [CS]"], "product_ndc": "59137-231", "generic_name": "AMINOLEVULINIC ACID HYDROCHLORIDE", "labeler_name": "Medexus Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GLEOLAN", "active_ingredients": [{"name": "AMINOLEVULINIC ACID HYDROCHLORIDE", "strength": "1500 mg/1"}], "application_number": "NDA208630", "marketing_category": "NDA", "marketing_start_date": "20180414", "listing_expiration_date": "20261231"}