What is NDC 65757-404?

65757-404 is the product NDC for aripiprazole lauroxil, Aripiprazole lauroxil 1064 mg/3.9mL injection, suspension, extended release, listed with the FDA by Alkermes, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Alkermes, Inc., NDC labeler code 65757. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for aripiprazole lauroxil?

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.

aripiprazole lauroxil NDC 65757-404

Unfinished product

This listing is a drug for further processing, not a finished drug product dispensed or administered to patients. It is not normally billed.

NDC codes

FDA NDC Directory

Product NDC (as listed)65757-404Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65757-0404Add 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
65757-404-00	6575704040065757040400	20 TRAY in 1 CARTON (65757-404-00) / 15 SYRINGE in 1 TRAY / 3.9 mL in 1 SYRINGEMarketed from 05-JUN-17

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

Generic name (nonproprietary): aripiprazole lauroxil
Active ingredients: Aripiprazole lauroxil — 1064 mg/3.9mL
Dosage form: Injection, Suspension, Extended release
Labeler: Alkermes, Inc.NDC labeler code 65757
Product type: Drug for further processing
Marketing category: Drug for further processing
Marketing start: Jun 5, 2017
Listing expires: Dec 31, 2026
Identifiers: Product ID 65757-404_ba3f1fc1-2263-4c0a-81d1-2f068edbca72SPL ID ba3f1fc1-2263-4c0a-81d1-2f068edbca72

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.

NDC on a medical claim

N465757040400 followed by a unit qualifier and the quantity

Package 65757-0404-00. 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.

About NDC 65757-404

What is NDC 65757-404?: 65757-404 is the product NDC for aripiprazole lauroxil, Aripiprazole lauroxil 1064 mg/3.9mL injection, suspension, extended release, listed with the FDA by Alkermes, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: aripiprazole lauroxil.
What is the active ingredient?: Aripiprazole lauroxil.
Who is the labeler?: Alkermes, Inc., NDC labeler code 65757. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for aripiprazole lauroxil?: 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.