What is NDC 69616-264?

69616-264 is the product NDC for Agamree (vamorolone) kit, listed with the FDA by Catalyst Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Catalyst Pharmaceuticals, Inc., NDC labeler code 69616. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Agamree?

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.

Agamree NDC 69616-264 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69616-264Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69616-0264Add 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
69616-264-38	69616026438	1 KIT in 1 CARTON (69616-264-38) * 100 mL in 1 BOTTLE, GLASS (69616-265-38)Marketed from Feb 1, 2024

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): Agamree
Generic name (nonproprietary): vamorolone
Dosage form: Kit
Route: Oral
Labeler: Catalyst Pharmaceuticals, Inc.NDC labeler code 69616
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 215239
Marketing start: Feb 1, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 69616-264_8e502b8a-7d2d-476b-8516-6678cfefbe32SPL ID 8e502b8a-7d2d-476b-8516-6678cfefbe32SPL set ID fb376f09-cf9c-42b5-b4dd-02d5bcd73211RxCUI 2669804, 2669810UPC 0369616265389, 0369616264382

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

N469616026438 followed by a unit qualifier and the quantity

Package 69616-0264-38. 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 22, 2026.

Indications (excerpt from the label)

AGAMREE is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. AGAMREE is a corticosteroid indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 2 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69616-264

What is NDC 69616-264?: 69616-264 is the product NDC for Agamree (vamorolone) kit, listed with the FDA by Catalyst Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Agamree (Vamorolone).
Who is the labeler?: Catalyst Pharmaceuticals, Inc., NDC labeler code 69616. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Agamree?: 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.

Agamree (Vamorolone) NDC 69616-264