Prescription drug · ANDA
Aripiprazole NDC 68788-7808
Aripiprazole 10 mg/1 · Tablet · Oral · Prefferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-7808-1 | 6878878080168788780801 | 100 TABLET in 1 BOTTLE (68788-7808-1)Marketed from Oct 28, 2020 | |
| 68788-7808-2 | 6878878080268788780802 | 20 TABLET in 1 BOTTLE (68788-7808-2)Marketed from Oct 28, 2020 | |
| 68788-7808-3 | 6878878080368788780803 | 30 TABLET in 1 BOTTLE (68788-7808-3)Marketed from Oct 28, 2020 | |
| 68788-7808-6 | 6878878080668788780806 | 60 TABLET in 1 BOTTLE (68788-7808-6)Marketed from Oct 28, 2020 | |
| 68788-7808-9 | 6878878080968788780809 | 90 TABLET in 1 BOTTLE (68788-7808-9)Marketed from Oct 28, 2020 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Prefferred Pharmaceuticals Inc.NDC labeler code 68788
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207105
- Marketing start
- Listing expires
- Identifiers
- Product ID 68788-7808_640953ec-6b90-4317-88db-233fe18656bdSPL ID 640953ec-6b90-4317-88db-233fe18656bdSPL set ID fbb3ac69-8dba-42df-8d6d-ef3d79241edbRxCUI 349545UNII 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
N468788780801followed by a unit qualifier and the quantityPackage 68788-7808-01. 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.
About NDC 68788-7808
- What is NDC 68788-7808?
- 68788-7808 is the product NDC for Aripiprazole, Aripiprazole 10 mg/1 tablet, listed with the FDA by Prefferred Pharmaceuticals Inc.. It has 5 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?
- Prefferred Pharmaceuticals Inc., NDC labeler code 68788. 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 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 2 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3725 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Direct_Rx | 72189-466 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7733 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Direct_Rx | 72189-476 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Coupler LLC | 67046-0885 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1903 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Coupler LLC | 67046-1052 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1935 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2806 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2820 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2869 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2897 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1980 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1687 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2369 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2974 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | A-S Medication Solutions | 50090-4665 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Coupler LLC | 67046-2046 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8089 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3090 |
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