Prescription drug · ANDA
Aripiprazole (aripiprazole orally disintegrating) NDC 50228-330
Aripiprazole 10 mg/1 · Tablet · Oral · ScieGen Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-330-30 | 50228033030 | 30 TABLET in 1 BOTTLE (50228-330-30)Marketed from Apr 18, 2018 | |
| 50228-330-51 | 50228033051 | 30 TABLET in 1 BLISTER PACK (50228-330-51)Marketed from Apr 18, 2018 |
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 orally disintegrating
- Active ingredients
- Aripiprazole — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207240
- Marketing start
- Listing expires
- Identifiers
- Product ID 50228-330_26d18fe2-326d-4214-e063-6394a90a691dSPL ID 26d18fe2-326d-4214-e063-6394a90a691dSPL set ID 4bcfd5a7-bec7-4426-9314-17daaf715cadRxCUI 349490, 349545UNII 82VFR53I78UPC 0350228330305, 0350228331302
- 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
N450228033030followed by a unit qualifier and the quantityPackage 50228-0330-30. 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) ] Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [ see Clinical Studies (14.2) ] Adjunctive Treatment of Major Depressive Disorder [see Clinical Studies (14.3) ] 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 ) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I ( 14.2 ) Adjunctive Treatment of Major Depressive Disorder ( 14.3 )…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207240
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 |
|---|---|---|---|---|
| Aripiprazolearipiprazole orally disintegrating | Aripiprazole 15 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-331 |
| Aripiprazolearipiprazole orally disintegrating | Aripiprazole 15 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc | 43598-734 |
| Aripiprazolearipiprazole orally disintegrating | Aripiprazole 10 mg/1 | TabletOral | Dr. Reddy's Laboratories Inc | 43598-733 |