Prescription drug · NDA
Rexulti (brexpiprazole) NDC 70518-3548
Brexpiprazole 2 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3548-1 | 70518354801 | 50 POUCH in 1 BOX (70518-3548-1) / 1 TABLET in 1 POUCH (70518-3548-2)Marketed from Apr 22, 2026 |
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)
- Rexulti
- Generic name (nonproprietary)
- brexpiprazole
- Active ingredients
- Brexpiprazole — 2 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205422
- Marketing start
- Listing expires
- Identifiers
- Product ID 70518-3548_5349e703-202b-6414-e063-6294a90a59aaSPL ID 5349e703-202b-6414-e063-6294a90a59aaSPL set ID 6991c065-0f6e-433a-8f4f-796e0ece327fRxCUI 1658335, 1658337UNII 2J3YBM1K8C
- 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
N470518354801followed by a unit qualifier and the quantityPackage 70518-3548-01. 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)
REXULTI is indicated for: Adjunctive treatment to antidepressants for major depressive disorder (MDD) in adults Treatment of schizophrenia in adults and pediatric patients ages 13 years and older Treatment of agitation associated with dementia due to Alzheimer's disease Limitations of Use: REXULTI is not indicated as an as needed ("prn") treatment for agitation associated with dementia due to Alzheimer's disease [see Clinical Studies (14.3) ] . REXULTI is an atypical antipsychotic indicated for: Use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD) in adults ( 1 , 14.1 ) Treatment of schizophrenia in adults and pediatric patients ages 13 years a…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 205422
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 |
|---|---|---|---|---|
| Rexultibrexpiprazole | Brexpiprazole 1 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-037 |
| Rexultibrexpiprazole | Brexpiprazole .25 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-035 |
| Rexultibrexpiprazole | Brexpiprazole .5 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-036 |
| Rexultibrexpiprazole | — | Kit | Otsuka America Pharmaceutical, Inc. | 59148-042 |
| Rexultibrexpiprazole | Brexpiprazole 2 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-038 |
| Rexultibrexpiprazole | Brexpiprazole 3 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-039 |
| Rexultibrexpiprazole | Brexpiprazole 4 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-040 |
| Rexultibrexpiprazole | — | Kit | Otsuka America Pharmaceutical, Inc. | 59148-044 |
| Rexultibrexpiprazole | Brexpiprazole 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4608 |