Prescription drug · ANDA
aripiprazole NDC 50090-6563
Aripiprazole 5 mg/1 · Tablet · Oral · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-6563-0 | 50090656300 | 30 TABLET in 1 BOTTLE (50090-6563-0)Marketed from Jul 18, 2023 | |
| 50090-6563-1 | 50090656301 | 90 TABLET in 1 BOTTLE (50090-6563-1)Marketed from Jul 18, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- aripiprazole
- Generic name (nonproprietary)
- aripiprazole
- Active ingredients
- Aripiprazole — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201519
- Marketing start
- Listing expires
- Identifiers
- Product ID 50090-6563_864c7f42-f10f-4f87-a3a8-4075a10374d1SPL ID 864c7f42-f10f-4f87-a3a8-4075a10374d1SPL set ID ab3973f3-3db8-4db2-8258-1b21af7b6380RxCUI 402131UNII 82VFR53I78
- 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 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
N450090656300followed by a unit qualifier and the quantityPackage 50090-6563-00. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
Aripiprazole Tablets are an atypical antipsychotic. The oral formulations are indicated for: Schizophrenia ( 14.1 ) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I ( 14.2 ) Adjunctive Treatment of Major Depressive Disorder ( 14.3 ) Irritability Associated with Autistic Disorder ( 14.4 ) Treatment of Tourette's disorder ( 14.5 ) Aripiprazole Oral Tablets are indicated for the treatment of: Schizophrenia Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder Adjunctive Treatment of Major Depressive Disorder Irritability Associated with Autistic Disorder Treatment of Tourette's Disorder
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201519
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 |
|---|---|---|---|---|
| aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-216 |
| aripiprazole | Aripiprazole 20 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-691 |
| aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-219 |
| aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-217 |
| aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-218 |
| aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-7063 |
| aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-220 |
| aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Torrent Pharmaceuticals Limited | 13668-221 |
| aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0412 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Direct_Rx | 72189-455 |
| aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Proficient Rx LP | 82804-235 |
| aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6656 |
| aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Proficient Rx LP | 82804-236 |
| aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7003 |
| aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7108 |
| aripiprazole | Aripiprazole 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2584 |
| aripiprazole | Aripiprazole 15 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2643 |