Prescription drug · ANDA
Aripiprazole NDC 76483-100
Aripiprazole 10 mg/1 · Tablet, Orally disintegrating · Oral · SQUARE PHARMACEUTICALS LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76483-100-00 | 76483010000 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-00)Marketed from Jul 20, 2022 | |
| 76483-100-01 | 76483010001 | 60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-01)Marketed from Jul 20, 2022 | |
| 76483-100-02 | 76483010002 | 90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-02)Marketed from Jul 20, 2022 | |
| 76483-100-03 | 76483010003 | 120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-03)Marketed from Jul 20, 2022 | |
| 76483-100-04 | 76483010004 | 30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (76483-100-04)Marketed from Feb 22, 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, Orally disintegrating
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090165
- Marketing start
- Listing expires
- Identifiers
- Product ID 76483-100_d7622fbb-a43c-46db-bde4-d05ed7bff185SPL ID d7622fbb-a43c-46db-bde4-d05ed7bff185SPL set ID 0f9b1fd8-a648-45c9-8655-14de07439f34RxCUI 643019, 643022, 643027, 643058UNII 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
N476483010000followed by a unit qualifier and the quantityPackage 76483-0100-00. 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 .
Other NDCs under ANDA 090165
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 | Tablet, Orally disintegratingOral | SQUARE PHARMACEUTICALS LIMITED | 76483-101 |
| Aripiprazole | Aripiprazole 20 mg/1 | Tablet, Orally disintegratingOral | SQUARE PHARMACEUTICALS LIMITED | 76483-102 |
| Aripiprazole | Aripiprazole 30 mg/1 | Tablet, Orally disintegratingOral | SQUARE PHARMACEUTICALS LIMITED | 76483-103 |
| Aripiprazole | Aripiprazole 10 mg/1 | Tablet, Orally disintegratingOral | Viona Pharmaceuticals Inc. | 72578-106 |
| Aripiprazole | Aripiprazole 15 mg/1 | Tablet, Orally disintegratingOral | Viona Pharmaceuticals Inc. | 72578-107 |