Prescription drug · ANDA
Aripiprazole NDC 59651-515
Aripiprazole 15 mg/1 · Tablet, Orally disintegrating · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-515-03 | 59651051503 | 3 BLISTER PACK in 1 CARTON (59651-515-03) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACKMarketed from Feb 18, 2026 | |
| 59651-515-30 | 59651051530 | 30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (59651-515-30)Marketed from Feb 18, 2026 |
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 — 15 mg/1
- Dosage form
- Tablet, Orally disintegrating
- Route
- Oral
- Labeler
- Aurobindo Pharma LimitedNDC labeler code 59651
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 216208
- Marketing start
- Listing expires
- Identifiers
- Product ID 59651-515_da73c5ab-4841-4081-8fdf-adc2ea343dcbSPL ID da73c5ab-4841-4081-8fdf-adc2ea343dcbSPL set ID 476b92f3-cf7b-4c09-ac67-6ed35e6811d5RxCUI 643019, 643022UNII 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
N459651051503followed by a unit qualifier and the quantityPackage 59651-0515-03. 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 orally disintegrating tablets are indicated for the treatment of: Schizophrenia [see Clinical Studies (14.1) ] Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [ see Clinical Studies (14.2) ] Irritability Associated with Autistic Disorder [see Clinical Studies (14.4) ] Treatment of Tourette’s Disorder [see Clinical Studies (14.5) ] Aripiprazole is 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 ) 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 59651-515
- What is NDC 59651-515?
- 59651-515 is the product NDC for Aripiprazole, Aripiprazole 15 mg/1 tablet, orally disintegrating, listed with the FDA by Aurobindo Pharma Limited. It has 2 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?
- Aurobindo Pharma Limited, NDC labeler code 59651. 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?
- 256 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 15 mg/1 | TabletOral | Coupler LLC | 67046-2046 | 67046-2046-03 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Coupler LLC | 67046-1052 | 67046-1052-03 |
| 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 216208
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 10 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 59651-514 |