Prescription drug · ANDA
Aripiprazole NDC 82804-023
Aripiprazole 10 mg/1 · Tablet · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-023-30 | 8280400233082804002330 | 30 TABLET in 1 BOTTLE (82804-023-30)Marketed from Oct 11, 2023 | |
| 82804-023-60 | 8280400236082804002360 | 60 TABLET in 1 BOTTLE (82804-023-60)Marketed from Oct 11, 2023 | |
| 82804-023-90 | 8280400239082804002390 | 90 TABLET in 1 BOTTLE (82804-023-90)Marketed from Oct 11, 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
- Route
- Oral
- Labeler
- Proficient Rx LPNDC labeler code 82804
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203908
- Marketing start
- Listing expires
- Identifiers
- Product ID 82804-023_fbd81df7-8482-493e-bfc5-a3352f466b9eSPL ID fbd81df7-8482-493e-bfc5-a3352f466b9eSPL set ID fbd81df7-8482-493e-bfc5-a3352f466b9eRxCUI 349545UNII 82VFR53I78UPC 0382804023301
- 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
N482804002330followed by a unit qualifier and the quantityPackage 82804-0023-30. 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 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.
About NDC 82804-023
- What is NDC 82804-023?
- 82804-023 is the product NDC for Aripiprazole, Aripiprazole 10 mg/1 tablet, listed with the FDA by Proficient Rx LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Aripiprazole.
- What is the active ingredient?
- Aripiprazole.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Aripiprazole?
- 254 other product NDCs are listed under this name. See all Aripiprazole NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Aripiprazole products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4745 | 70518-4745-00 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Coupler LLC | 67046-0873 | 67046-0873-03 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Coupler LLC | 67046-1052 | 67046-1052-03 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Coupler LLC | 67046-2046 | 67046-2046-03 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-006 | 87441-0006-01 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Coupler LLC | 67046-1085 | 67046-1085-03 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Coupler LLC | 67046-0885 | 67046-0885-03 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Coupler LLC | 67046-1017 | 67046-1017-03 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Coupler LLC | 67046-0492 | 67046-0492-03 |
| Aripiprazole | Aripiprazole 10 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 59651-514 | 59651-0514-0359651-0514-30 |
Other NDCs under ANDA 203908
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 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-6403 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-7564 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-661 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-662 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-664 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4745 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Proficient Rx LP | 71205-392 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Proficient Rx LP | 71205-480 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1364 |