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NDC 65757-0500-03 ARISTADA INITIO 675 mg/2.4mL Details
ARISTADA INITIO 675 mg/2.4mL
ARISTADA INITIO is a INTRAMUSCULAR INJECTION, SUSPENSION, EXTENDED RELEASE in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Alkermes, Inc.. The primary component is ARIPIPRAZOLE LAUROXIL.
MedlinePlus Drug Summary
Aripiprazole extended-release injection (Abilify Maintena, Aristada, Aristada Initio) is used alone or in combination with other aripiprazole preparations to treat schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). Aripiprazole extended-release injection (Abilify Maintena) is also used for the ongoing treatment of people with bipolar I disorder (manic-depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Aripiprazole is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.
Related Packages: 65757-0500-03Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Aripiprazole Injection
Product Information
| NDC | 65757-0500 |
|---|---|
| Product ID | 65757-500_64c04e28-0c78-42d4-af87-6c45ab6fbb46 |
| Associated GPIs | 5925001520E435 |
| GCN Sequence Number | 078588 |
| GCN Sequence Number Description | aripiprazole lauroxil,submicr. SUSER SYR 675 MG/2.4 INTRAMUSC |
| HIC3 | H7X |
| HIC3 Description | ANTIPSYCHOTICS, ATYP, D2 PARTIAL AGONIST/5HT MIXED |
| GCN | 44941 |
| HICL Sequence Number | 045050 |
| HICL Sequence Number Description | ARIPIPRAZOLE LAUROXIL, SUBMICRONIZED |
| Brand/Generic | Brand |
| Proprietary Name | ARISTADA INITIO |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | aripiprazole lauroxil |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SUSPENSION, EXTENDED RELEASE |
| Route | INTRAMUSCULAR |
| Active Ingredient Strength | 675 |
| Active Ingredient Units | mg/2.4mL |
| Substance Name | ARIPIPRAZOLE LAUROXIL |
| Labeler Name | Alkermes, Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA209830 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 65757-0500-03 (65757050003)
| NDC Package Code | 65757-500-03 |
|---|---|
| Billing NDC | 65757050003 |
| Package | 1 SYRINGE in 1 CARTON (65757-500-03) / 2.4 mL in 1 SYRINGE |
| Marketing Start Date | 2018-06-29 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |