Prescription drug · ANDA
Aripiprazole NDC 43547-307
Aripiprazole 30 mg/1 · Tablet · Oral · Solco Healthcare U.S., LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-307-03 | 43547030703 | 30 TABLET in 1 BOTTLE (43547-307-03)Marketed from Dec 4, 2017 | |
| 43547-307-09 | 43547030709 | 90 TABLET in 1 BOTTLE (43547-307-09)Marketed from Dec 4, 2017 | |
| 43547-307-10 | 43547030710 | 100 TABLET in 1 BOTTLE (43547-307-10)Marketed from Dec 4, 2017 | |
| 43547-307-50 | 43547030750 | 500 TABLET in 1 BOTTLE (43547-307-50)Marketed from Dec 4, 2017 |
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 — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Solco Healthcare U.S., LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205363
- Marketing start
- Listing expires
- Identifiers
- Product ID 43547-307_1f3b82ac-31e8-481a-adc5-dbfc29362ffdSPL ID 1f3b82ac-31e8-481a-adc5-dbfc29362ffdSPL set ID 686d0088-ac61-41df-8909-ae12f7957644RxCUI 349490, 349545, 349547, 349553, 402131, 602964UNII 82VFR53I78UPC 0343547307103
- 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
N443547030703followed by a unit qualifier and the quantityPackage 43547-0307-03. 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 indicated for the treatment of: • Schizophrenia • Irritability Associated with Autistic Disorder • Treatment of Tourette’s Disorder 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 205363
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 | A-S Medication Solutions | 50090-7105 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Solco Healthcare U.S., LLC | 43547-885 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Solco Healthcare U.S., LLC | 43547-884 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Solco Healthcare U.S., LLC | 43547-886 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Solco Healthcare U.S., LLC | 43547-887 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Solco Healthcare U.S., LLC | 43547-888 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Solco Healthcare U.S., LLC | 43547-889 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Solco Healthcare U.S., LLC | 43547-304 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Solco Healthcare U.S., LLC | 43547-302 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Solco Healthcare U.S., LLC | 43547-303 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Solco Healthcare U.S., LLC | 43547-305 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Solco Healthcare U.S., LLC | 43547-306 |