Ameluz (aminolevulinic acid hydrochloride) NDC 70621-101

NDC codes

FDA NDC Directory

Product NDC (as listed)70621-101Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70621-0101Add 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
70621-101-10	70621010110	1 TUBE in 1 PACKAGE (70621-101-10) / 2 g in 1 TUBE (70621-101-01)Marketed from Jun 1, 2017
70621-101-20	70621010120	10 TUBE in 1 PACKAGE (70621-101-20) / 2 g in 1 TUBE (70621-101-01)Marketed from May 10, 2021
70621-101-30	70621010130	1 TUBE in 1 PACKAGE (70621-101-30) / 2 g in 1 TUBE (70621-101-03)Marketed from Jun 1, 2017 · Sample package

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): Ameluz
Generic name (nonproprietary): aminolevulinic acid hydrochloride
Active ingredients: Aminolevulinic acid hydrochloride — 100 mg/g
Dosage form: Gel
Route: Topical
Labeler: Biofrontera Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208081
Marketing start: Aug 26, 2016
Listing expires: Dec 31, 2027
Other FDA classes: Fluorescence Contrast Activity (Mechanism)Porphyrinogens (Chemical structure)
Identifiers: Product ID 70621-101_727af849-5f31-4168-85a1-c2a12d0fb43aSPL ID 727af849-5f31-4168-85a1-c2a12d0fb43a
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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N470621010110 followed by a unit qualifier and the quantity

Package 70621-0101-10. 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

The FDA listing for this product does not reference a label (SPL) set.