Prescription drug · ANDA
Aripiprazole NDC 54838-570
Aripiprazole 1 mg/mL · Solution · Oral · Lannett Company, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54838-570-59 | 54838057059 | 150 mL in 1 BOTTLE, PLASTIC (54838-570-59)Marketed from Aug 17, 2015 | |
| 54838-570-70 | 54838057070 | 237 mL in 1 BOTTLE, PLASTIC (54838-570-70)Marketed from Aug 17, 2015 |
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 — 1 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Lannett Company, Inc.NDC labeler code 54838
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204171
- Marketing start
- Listing expires
- Identifiers
- Product ID 54838-570_de0ee6f0-d4d7-4d86-9ff9-3ee2c687fcccSPL ID de0ee6f0-d4d7-4d86-9ff9-3ee2c687fcccSPL set ID e7292c4c-e332-4ed4-9086-f130d223b6aeRxCUI 485496UNII 82VFR53I78UPC 0354838570595
- 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
N454838057059followed by a unit qualifier and the quantityPackage 54838-0570-59. 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 Oral Solution is 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 formulations are 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 54838-570
- What is NDC 54838-570?
- 54838-570 is the product NDC for Aripiprazole, Aripiprazole 1 mg/mL solution, listed with the FDA by Lannett Company, Inc.. 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?
- Lannett Company, Inc., NDC labeler code 54838. 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 |