Prescription drug · NDA
Aristada (Aripiprazole lauroxil) NDC 65757-403
Aripiprazole lauroxil 882 mg/3.2mL · Injection, Suspension, Extended release · Intramuscular · Alkermes, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65757-403-03 | 6575704030365757040303 | 1 SYRINGE in 1 CARTON (65757-403-03) / 3.2 mL in 1 SYRINGEMarketed from Oct 5, 2015 | |
| 65757-403-04 | 6575704030465757040304 | 1 SYRINGE in 1 CARTON (65757-403-04) / 3.2 mL in 1 SYRINGEMarketed from Oct 5, 2015 · 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
- Generic name (nonproprietary)
- aripiprazole lauroxil
- Active ingredients
- Aripiprazole lauroxil — 882 mg/3.2mL
- 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 207533
- Marketing start
- Listing expires
- Identifiers
- Product ID 65757-403_3d951a36-1e73-4f84-8ebf-4d556d81a086SPL ID 3d951a36-1e73-4f84-8ebf-4d556d81a086SPL set ID 17a8d11b-73b0-4833-a0b4-cf1ef85edefbRxCUI 1673269, 1673274, 1673277, 1673278, 1673279, 1673280, 1925262, 1925264UNII 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
N465757040303followed by a unit qualifier and the quantityPackage 65757-0403-03. 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 is indicated for the treatment of schizophrenia in adults [see Clinical Studies ( 14 )]. ARISTADA is an atypical antipsychotic indicated for the treatment of schizophrenia in adults ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 65757-403
- What is NDC 65757-403?
- 65757-403 is the product NDC for Aristada (aripiprazole lauroxil), Aripiprazole lauroxil 882 mg/3.2mL 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 (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?
- 2 other product NDCs are listed under this name. See all Aristada NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Aristada products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Aristadaaripiprazole lauroxil | Aripiprazole lauroxil 441 mg/1.6mL | Injection, Suspension, Extended releaseIntramuscular | Alkermes, Inc. | 65757-401 | 65757-0401-0365757-0401-04 |
| Aristadaaripiprazole lauroxil | Aripiprazole lauroxil 662 mg/2.4mL | Injection, Suspension, Extended releaseIntramuscular | Alkermes, Inc. | 65757-402 | 65757-0402-0365757-0402-04 |
Other NDCs under NDA 207533
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Aristadaaripiprazole lauroxil | Aripiprazole lauroxil 441 mg/1.6mL | Injection, Suspension, Extended releaseIntramuscular | Alkermes, Inc. | 65757-401 |
| Aristadaaripiprazole lauroxil | Aripiprazole lauroxil 662 mg/2.4mL | Injection, Suspension, Extended releaseIntramuscular | Alkermes, Inc. | 65757-402 |