gleolan

Generic: aminolevulinic acid hydrochloride

Labeler: nx development corp
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name gleolan
Generic Name aminolevulinic acid hydrochloride
Labeler nx development corp
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

aminolevulinic acid hydrochloride 1500 mg/1

Manufacturer
NX DEVELOPMENT CORP

Identifiers & Regulatory

Product NDC 71469-231
Product ID 71469-231_957499a8-90f5-4cbd-916d-abfd8251e1b4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208630
Listing Expiration 2027-12-31
Marketing Start 2018-03-14

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 71469231
Hyphenated Format 71469-231

Supplemental Identifiers

UPC
0371469231015
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 (71469-231-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

71469-231-01 1 VIAL, SINGLE-DOSE in 1 CARTON (71469-231-01) / 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": "957499a8-90f5-4cbd-916d-abfd8251e1b4", "openfda": {"upc": ["0371469231015"], "unii": ["V35KBM8JGR"], "spl_set_id": ["cdeded66-0017-42cf-9471-13f231014323"], "manufacturer_name": ["NX DEVELOPMENT CORP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (71469-231-01)  / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSE", "package_ndc": "71469-231-01", "marketing_start_date": "20180314"}], "brand_name": "GLEOLAN", "product_id": "71469-231_957499a8-90f5-4cbd-916d-abfd8251e1b4", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Fluorescence Contrast Activity [MoA]", "Optical Imaging Agent [EPC]", "Porphyrin Precursor [EPC]", "Porphyrinogens [CS]"], "product_ndc": "71469-231", "generic_name": "AMINOLEVULINIC ACID HYDROCHLORIDE", "labeler_name": "NX DEVELOPMENT CORP", "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": "20180314", "listing_expiration_date": "20271231"}