Prescription drug · ANDA
Aripiprazole NDC 69452-339
Aripiprazole 15 mg/1 · Tablet, Orally disintegrating · Oral · Bionpharma Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69452-339-13 | 69452033913 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (69452-339-13)Marketed from Feb 7, 2022 |
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 — 15 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Bionpharma Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202547
- Marketing start
- Listing expires
- Identifiers
- Product ID 69452-339_a104bd7b-2748-450c-b4d3-9e96ccf2939dSPL ID a104bd7b-2748-450c-b4d3-9e96ccf2939dSPL set ID 720bc395-777d-4e5d-9571-aad5827dbf6dRxCUI 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
N469452033913followed by a unit qualifier and the quantityPackage 69452-0339-13. 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 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 Aripiprazole orally disintegrating 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)
Excerpt only. Read the full label for complete information.