Prescription drug · ANDA
Aripiprazole NDC 71335-1364
Aripiprazole 20 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1364-1 | 71335136401 | 30 TABLET in 1 BOTTLE (71335-1364-1)Marketed from Oct 4, 2019 | |
| 71335-1364-2 | 71335136402 | 28 TABLET in 1 BOTTLE (71335-1364-2)Marketed from Oct 4, 2019 | |
| 71335-1364-3 | 71335136403 | 90 TABLET in 1 BOTTLE (71335-1364-3)Marketed from Oct 4, 2019 |
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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203908
- Marketing start
- Listing expires
- Identifiers
- Product ID 71335-1364_33ef68d4-e036-9fd1-e063-6394a90a6d2dSPL ID 33ef68d4-e036-9fd1-e063-6394a90a6d2dSPL set ID 385301f5-e59d-42d5-8544-aadf0ee0c967RxCUI 349553UNII 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
N471335136401followed by a unit qualifier and the quantityPackage 71335-1364-01. 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 tablets are indicated for the treatment of: Schizophrenia [see Clinical Studies (14.1) ] Treatment of Tourette’s Disorder [see Clinical Studies (14.5) ] Aripiprazole is an atypical antipsychotic. The oral formulation is indicated for: Schizophrenia (14.1) Treatment of Tourette’s disorder ( 14.5 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 203908
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 | A-S Medication Solutions | 50090-6403 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-662 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-661 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-666 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-663 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-664 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Aurobindo Pharma Limited | 65862-665 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4745 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Proficient Rx LP | 71205-392 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Proficient Rx LP | 71205-480 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Proficient Rx LP | 82804-023 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | A-S Medication Solutions | 50090-7564 |