Prescription drug · ANDA
Aripiprazole NDC 68788-8089
Aripiprazole 5 mg/1 · Tablet · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8089-1 | 68788808901 | 100 TABLET in 1 BOTTLE (68788-8089-1)Marketed from Oct 5, 2021 | |
| 68788-8089-2 | 68788808902 | 20 TABLET in 1 BOTTLE (68788-8089-2)Marketed from Oct 5, 2021 | |
| 68788-8089-3 | 68788808903 | 30 TABLET in 1 BOTTLE (68788-8089-3)Marketed from Oct 5, 2021 | |
| 68788-8089-6 | 68788808906 | 60 TABLET in 1 BOTTLE (68788-8089-6)Marketed from Oct 5, 2021 | |
| 68788-8089-9 | 68788808909 | 90 TABLET in 1 BOTTLE (68788-8089-9)Marketed from Oct 5, 2021 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207105
- Marketing start
- Listing expires
- Identifiers
- Product ID 68788-8089_3f8e2e09-8030-4d81-ad7e-4ae76aa7ecafSPL ID 3f8e2e09-8030-4d81-ad7e-4ae76aa7ecafSPL set ID 34127431-6ad7-402f-bc22-1429c55d921cRxCUI 402131UNII 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
N468788808901followed by a unit qualifier and the quantityPackage 68788-8089-01. 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 Oral 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 tablets are 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 ) • 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 207105
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 15 mg/1 | TabletOral | Coupler LLC | 67046-2046 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2974 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-431 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-430 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-432 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-433 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-434 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Ascend Laboratories, LLC | 67877-435 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3090 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1832 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Coupler LLC | 67046-0492 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-4665 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Direct_Rx | 72189-466 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Direct_Rx | 72189-476 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1903 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | A-S Medication Solutions | 50090-4863 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3725 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1935 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-4936 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Coupler LLC | 67046-0885 |
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