Prescription drug · ANDA
Aripiprazole NDC 72578-106
Aripiprazole 10 mg/1 · Tablet, Orally disintegrating · Oral · Viona Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72578-106-06 | 72578010606 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (72578-106-06)Marketed from Jul 20, 2022 | |
| 72578-106-78 | 72578010678 | 3 BLISTER PACK in 1 CARTON (72578-106-78) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (72578-106-30)Marketed from Feb 22, 2023 |
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)
- Aripiprazole
- Generic name (nonproprietary)
- aripiprazole
- Active ingredients
- Aripiprazole — 10 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Viona Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090165
- Marketing start
- Listing expires
- Identifiers
- Product ID 72578-106_62486381-abea-40d9-aa88-bf3f3665a65fSPL ID 62486381-abea-40d9-aa88-bf3f3665a65fSPL set ID 73c5e380-b7b1-4362-a827-71881574ff48RxCUI 643019, 643022UNII 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
N472578010606followed by a unit qualifier and the quantityPackage 72578-0106-06. 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 orally disintegrating tablets are indicated for the treatment of: Schizophrenia [see Clinical Studies (14.1)] Irritability Associated with Autistic Disorder [ see Clinical Studies (14.4) ] Treatment of Tourette's Disorder [see Clinical Studies (14.5)] Aripiprazole is an atypical antipsychotic. The oral formulation is indicated for: Schizophrenia (14.1) Irritability Associated with Autistic Disorder ( 14.4 ) Treatment of Tourette's disorder (14.5)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090165
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 10 mg/1 | Tablet, Orally disintegratingOral | SQUARE PHARMACEUTICALS LIMITED | 76483-100 |
| Aripiprazole | Aripiprazole 15 mg/1 | Tablet, Orally disintegratingOral | SQUARE PHARMACEUTICALS LIMITED | 76483-101 |
| Aripiprazole | Aripiprazole 20 mg/1 | Tablet, Orally disintegratingOral | SQUARE PHARMACEUTICALS LIMITED | 76483-102 |
| Aripiprazole | Aripiprazole 30 mg/1 | Tablet, Orally disintegratingOral | SQUARE PHARMACEUTICALS LIMITED | 76483-103 |
| Aripiprazole | Aripiprazole 15 mg/1 | Tablet, Orally disintegratingOral | Viona Pharmaceuticals Inc. | 72578-107 |