Prescription drug · ANDA
Aripiprazole NDC 62135-904
Aripiprazole 1 mg/mL · Solution · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-904-51 | 62135090451 | 150 mL in 1 BOTTLE (62135-904-51)Marketed from Apr 28, 2025 |
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
- Chartwell RX, LLCNDC labeler code 62135
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215595
- Marketing start
- Listing expires
- Identifiers
- Product ID 62135-904_3540f59e-f085-8760-e063-6394a90aae82SPL ID 3540f59e-f085-8760-e063-6394a90aae82SPL set ID 1d27462e-45c7-4335-9092-84c340e06a2cRxCUI 485496UNII 82VFR53I78UPC 0362135904517
- 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
N462135090451followed by a unit qualifier and the quantityPackage 62135-0904-51. 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) ] Adjunctive Treatment of Major Depressive Disorder [see Clinical Studies (14.3) ] 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 ) Adjunctive Treatment of Major Depressive Disorder ( 14.3 ) Irritability As…
Excerpt only. Read the full label for complete information.
About NDC 62135-904
- What is NDC 62135-904?
- 62135-904 is the product NDC for Aripiprazole, Aripiprazole 1 mg/mL solution, listed with the FDA by Chartwell RX, LLC. 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?
- Chartwell RX, LLC, NDC labeler code 62135. 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 15 mg/1 | TabletOral | Coupler LLC | 67046-2046 | 67046-2046-03 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Coupler LLC | 67046-1052 | 67046-1052-03 |
| 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 |