Prescription drug · NDA
Aristada Initio (Aripiprazole lauroxil) NDC 65757-500
Aripiprazole lauroxil 675 mg/2.4mL · Injection, Suspension, Extended release · Intramuscular · Alkermes, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65757-500-03 | 6575705000365757050003 | 1 SYRINGE in 1 CARTON (65757-500-03) / 2.4 mL in 1 SYRINGEMarketed from Jun 29, 2018 | |
| 65757-500-04 | 6575705000465757050004 | 1 SYRINGE in 1 CARTON (65757-500-04) / 2.4 mL in 1 SYRINGEMarketed from Jun 29, 2018 · 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)
- Aristada Initio
- Generic name (nonproprietary)
- aripiprazole lauroxil
- Active ingredients
- Aripiprazole lauroxil — 675 mg/2.4mL
- Dosage form
- Injection, Suspension, Extended release
- Route
- Intramuscular
- Labeler
- Alkermes, Inc.NDC labeler code 65757
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209830
- Marketing start
- Listing expires
- Identifiers
- Product ID 65757-500_cbde23b9-60d1-4ae1-b42d-1093610ba18dSPL ID cbde23b9-60d1-4ae1-b42d-1093610ba18dSPL set ID b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403RxCUI 2049341, 2049343UNII B786J7A343
- Pharmacologic class
- Atypical Antipsychotic
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.
- NDC on a medical claim
N465757050003followed by a unit qualifier and the quantityPackage 65757-0500-03. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
ARISTADA INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA when used for the treatment of schizophrenia in adults. ARISTADA INITIO, in combination with oral aripiprazole, is indicated for the initiation of ARISTADA ® when used for the treatment of schizophrenia in adults ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 65757-500
- What is NDC 65757-500?
- 65757-500 is the product NDC for Aristada Initio (aripiprazole lauroxil), Aripiprazole lauroxil 675 mg/2.4mL injection, suspension, extended release, listed with the FDA by Alkermes, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Aristada Initio (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 Aristada Initio?
- 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.