Gleolan (aminolevulinic acid hydrochloride) NDC 71469-231

NDC codes

FDA NDC Directory

Product NDC (as listed)71469-231Labeler and product segments. Claims need a package NDC.

Product NDC at billing width71469-0231Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
71469-231-01	71469023101	1 VIAL, SINGLE-DOSE in 1 CARTON (71469-231-01) / 1 POWDER, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Mar 14, 2018

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): Gleolan
Generic name (nonproprietary): aminolevulinic acid hydrochloride
Active ingredients: Aminolevulinic acid hydrochloride — 1500 mg/1
Dosage form: Powder, For solution
Route: Oral
Labeler: NX DEVELOPMENT CORP
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208630
Marketing start: Mar 14, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Fluorescence Contrast Activity (Mechanism)Porphyrinogens (Chemical structure)
Identifiers: Product ID 71469-231_957499a8-90f5-4cbd-916d-abfd8251e1b4SPL ID 957499a8-90f5-4cbd-916d-abfd8251e1b4SPL set ID cdeded66-0017-42cf-9471-13f231014323UNII V35KBM8JGRUPC 0371469231015
Pharmacologic class: Optical Imaging Agent; Porphyrin Precursor

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N471469023101 followed by a unit qualifier and the quantity

Package 71469-0231-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 29, 2026.

Indications (excerpt from the label)

Gleolan is indicated in patients with glioma [suspected World Health Organization (WHO) Grades III or IV on preoperative imaging] as an adjunct for the visualization of malignant tissue during surgery. Gleolan is an optical imaging agent indicated in patients with glioma (suspected World Health Organization Grades III or IV on preoperative imaging) as an adjunct for the visualization of malignant tissue during surgery. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)