Prescription drug · ANDA
Aripiprazole NDC 67046-1638
Aripiprazole 2 mg/1 · Tablet · Oral · Coupler LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67046-1638-3 | 6704616380367046163803 | 30 TABLET in 1 BLISTER PACK (67046-1638-3)Marketed from Dec 31, 2025 |
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 — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Coupler LLCNDC labeler code 67046
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206174
- Marketing start
- Listing expires
- Identifiers
- Product ID 67046-1638_47430dfa-9331-6c31-e063-6394a90a86a9SPL ID 47430dfa-9331-6c31-e063-6394a90a86a9SPL set ID 47430dfa-9377-6c31-e063-6394a90a86a9RxCUI 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
N467046163803followed by a unit qualifier and the quantityPackage 67046-1638-03. 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)
AripiprazoleTabletsare indicated for the treatment of: Schizophrenia IrritabilityAssociatedwith Autistic Disorder TreatmentofTourette’s Disorder Aripiprazole is an atypical antipsychotic. Aripiprazole is 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 67046-1638
- What is NDC 67046-1638?
- 67046-1638 is the product NDC for Aripiprazole, Aripiprazole 2 mg/1 tablet, listed with the FDA by Coupler 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?
- Coupler LLC, NDC labeler code 67046. 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?
- 254 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 |
Other NDCs under ANDA 206174
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 2 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-051 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-052 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-053 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-054 |
| Aripiprazole | Aripiprazole 20 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-055 |
| Aripiprazole | Aripiprazole 30 mg/1 | TabletOral | Ajanta Pharma USA Inc. | 27241-056 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | A-S Medication Solutions | 50090-6409 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-7749 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-2736 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1513 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1515 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1682 |
| Aripiprazole | Aripiprazole 2 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-088 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-089 |
| Aripiprazole | Aripiprazole 10 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-090 |
| Aripiprazole | Aripiprazole 15 mg/1 | TabletOral | Quallent Pharmaceuticals Health LLC | 82009-091 |
| Aripiprazole | Aripiprazole 5 mg/1 | TabletOral | Unit Dose Solutions, Inc. | 87441-006 |