Prescription drug · ANDA
Aripiprazole NDC 65162-902
Aripiprazole 30 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-902-03 | 65162090203 | 30 TABLET in 1 BOTTLE (65162-902-03)Marketed from Jun 20, 2016 | |
| 65162-902-09 | 65162090209 | 90 TABLET in 1 BOTTLE (65162-902-09)Marketed from Jun 20, 2016 | |
| 65162-902-11 | 65162090211 | 1000 TABLET in 1 BOTTLE (65162-902-11)Marketed from Jun 20, 2016 | |
| 65162-902-50 | 65162090250 | 500 TABLET in 1 BOTTLE (65162-902-50)Marketed from Jun 20, 2016 |
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 — 30 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204838
- Marketing start
- Listing expires
- Identifiers
- Product ID 65162-902_c125d854-8bb2-4467-83b4-c8a0e0f893c8SPL ID c125d854-8bb2-4467-83b4-c8a0e0f893c8SPL set ID 06dda03f-8481-46d6-af02-4f51e1a3a065RxCUI 349490, 349545, 349547, 349553, 402131, 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
N465162090203followed by a unit qualifier and the quantityPackage 65162-0902-03. 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 Tablets are indicated for the treatment of: Schizophrenia Irritability Associated with Autistic Disorder Treatment of Tourette’s Disorder Aripiprazole tablets are an atypical antipsychotic. Aripiprazole tablets are 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 65162-902
- What is NDC 65162-902?
- 65162-902 is the product NDC for Aripiprazole, Aripiprazole 30 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 4 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?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 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 15 mg/1 | Tablet, Orally disintegratingOral | Aurobindo Pharma Limited | 59651-515 | 59651-0515-0359651-0515-30 |
Other NDCs under ANDA 204838
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 20 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7370 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7371 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-896 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-897 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-898 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-899 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-901 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-7774 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Proficient Rx LP | 63187-965 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7366 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7367 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7368 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-0970 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7369 |