NDC codes

FDA NDC Directory
Product NDC (as listed)73372-0116Labeler and product segments. Claims need a package NDC.
Product NDC at billing width73372-0116Add 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 NDC11-digit (billing)PackageCopy
73372-0116-1733720116011 VIAL, GLASS in 1 CARTON (73372-0116-1) / 1 mg in 1 VIAL, GLASSMarketed from Dec 31, 2019

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
Scenesse
Generic name (nonproprietary)
afamelanotide
Active ingredients
Afamelanotide — 16 mg/16mg
Dosage form
Implant
Route
Subcutaneous
Labeler
CLINUVEL INC.NDC labeler code 73372
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 210797
Marketing start
Listing expires
Identifiers
Product ID 73372-0116_5192f26d-d5e7-ce03-e063-6294a90a3ea2SPL ID 5192f26d-d5e7-ce03-e063-6294a90a3ea2SPL set ID 94f53286-11dd-7fbb-e053-2a95a90a7c48RxCUI 2262254, 2262259UNII QW68W3J66UUPC 0373372011616

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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N473372011601 followed by a unit qualifier and the quantity

Package 73372-0116-01. 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 .

Indications (excerpt from the label)

SCENESSE ® is indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP). SCENESSE is a melanocortin 1 receptor (MC1-R) agonist indicated to increase pain free light exposure in adult patients with a history of phototoxic reactions from erythropoietic protoporphyria (EPP)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 73372-0116

What is NDC 73372-0116?
73372-0116 is the product NDC for Scenesse (afamelanotide), Afamelanotide 16 mg/16mg implant, listed with the FDA by CLINUVEL INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Scenesse (Afamelanotide).
What is the active ingredient?
Afamelanotide.
Who is the labeler?
CLINUVEL INC., NDC labeler code 73372. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Scenesse?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

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