Prescription drug · ANDA
Aripiprazole NDC 0615-8525
Aripiprazole 10 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8525-39 | 00615852539 | 30 TABLET in 1 BLISTER PACK (0615-8525-39)Marketed from Sep 18, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- NCS HealthCare of KY, LLC dba Vangard LabsNDC labeler code 0615
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206383
- Marketing start
- Listing expires
- Identifiers
- Product ID 0615-8525_b4492067-a61a-4f62-a09a-ae26e8f35baaSPL ID b4492067-a61a-4f62-a09a-ae26e8f35baaSPL set ID d8183eaf-0093-4720-b8ed-20e570697511RxCUI 349545, 602964UNII 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
N400615852539followed by a unit qualifier and the quantityPackage 00615-8525-39. 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 0615-8525
- What is NDC 0615-8525?
- 0615-8525 is the product NDC for Aripiprazole, Aripiprazole 10 mg/1 tablet, listed with the FDA by NCS HealthCare of KY, LLC dba Vangard Labs. It has 1 package NDC, 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?
- NCS HealthCare of KY, LLC dba Vangard Labs, NDC labeler code 0615. 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?
- 251 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 206383
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 5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8375 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8524 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-554 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-555 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-556 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-557 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-558 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-559 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-965 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-966 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-967 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-968 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-969 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-970 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-324 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-325 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-326 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-327 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-328 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-329 |
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