Prescription drug · ANDA
Aripiprazole NDC 43598-554
Aripiprazole 2 mg/1 · Tablet · Oral · Dr.Reddys Laboratories Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-554-05 | 43598055405 | 500 TABLET in 1 BOTTLE (43598-554-05)Marketed from Sep 29, 2016 | |
| 43598-554-30 | 43598055430 | 30 TABLET in 1 BOTTLE (43598-554-30)Marketed from Sep 29, 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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Dr.Reddys Laboratories Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206383
- Marketing start
- Listing expires
- Identifiers
- Product ID 43598-554_7b98f7e8-e2a3-4c6c-a47c-b40a6da85f4cSPL ID 7b98f7e8-e2a3-4c6c-a47c-b40a6da85f4cSPL set ID 0aa7e178-456a-4942-93aa-9ec18a58939fRxCUI 349490, 349545, 349547, 349553, 402131, 602964UNII 82VFR53I78UPC 0343598558301, 0343598559308, 0343598554303, 0343598555300, 0343598556307, 0343598557304
- 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
N443598055405followed by a unit qualifier and the quantityPackage 43598-0554-05. 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 ) ] Additional pediatric use information is approved for Otsuka America Pharmaceutical, Inc.’s ABILIFY ® (aripiprazole) product. However, due to Otsuka America Pharmaceutical, Inc.’s marketing exclusivity rights, this drug product is not labeled with that information. Aripiprazole is an atypical antipsychotic. The oral formulation is indicated for: • Schizophrenia ( 14.1 )
Excerpt only. Read the full label for complete information.
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 15 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-968 |
| 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 20 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-969 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-970 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-326 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-324 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-325 |
| 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 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-557 |
| 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 20 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-558 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Dr.Reddys Laboratories Inc | 43598-559 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8375 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-475 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | ScieGen Pharmaceuticals Inc | 50228-479 |
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