Prescription drug · NDA
Rexulti (Brexpiprazole) NDC 59148-044
Kit · Otsuka America Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59148-044-14 | 59148004414 | 1 KIT in 1 CARTON (59148-044-14) * 7 TABLET in 1 BLISTER PACK * 7 TABLET in 1 BLISTER PACKMarketed from Jul 10, 2015 · Sample package |
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)
- Rexulti
- Generic name (nonproprietary)
- brexpiprazole
- Dosage form
- Kit
- Labeler
- Otsuka America Pharmaceutical, Inc.NDC labeler code 59148
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 205422
- Marketing start
- Listing expires
- Identifiers
- Product ID 59148-044_3a208135-0d99-4d6a-b73e-61d63cf48f4fSPL ID 3a208135-0d99-4d6a-b73e-61d63cf48f4fSPL set ID 2d301358-6291-4ec1-bd87-37b4ad9bd850RxCUI 1658319, 1658325, 1658327, 1658329, 1658331, 1658333, 1658335, 1658337, 1658339, 1658341, 1658343, 1658345UNII 2J3YBM1K8CUPC 0359148035130, 0359148040134, 0359148036137, 0359148038131, 0359148039138, 0359148037134
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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N459148004414followed by a unit qualifier and the quantityPackage 59148-0044-14. 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.
About NDC 59148-044
- What is NDC 59148-044?
- 59148-044 is the product NDC for Rexulti (brexpiprazole) kit, listed with the FDA by Otsuka America Pharmaceutical, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rexulti (Brexpiprazole).
- Who is the labeler?
- Otsuka America Pharmaceutical, Inc., NDC labeler code 59148. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rexulti?
- 9 other product NDCs are listed under this name. See all Rexulti NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rexulti products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rexultibrexpiprazole | Brexpiprazole 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4608 | 70518-4608-00 |
| Rexultibrexpiprazole | Brexpiprazole 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3548 | 70518-3548-01 |
| Rexultibrexpiprazole | Brexpiprazole .25 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-035 | 59148-0035-13 |
| Rexultibrexpiprazole | Brexpiprazole .5 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-036 | 59148-0036-0759148-0036-13 |
| Rexultibrexpiprazole | Brexpiprazole 1 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-037 | 59148-0037-0759148-0037-13 |
| Rexultibrexpiprazole | Brexpiprazole 2 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-038 | 59148-0038-0759148-0038-13 |
| Rexultibrexpiprazole | Brexpiprazole 3 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-039 | 59148-0039-0759148-0039-13 |
| Rexultibrexpiprazole | Brexpiprazole 4 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-040 | 59148-0040-0759148-0040-13 |
| Rexultibrexpiprazole | — | Kit | Otsuka America Pharmaceutical, Inc. | 59148-042 | 59148-0042-07 |
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 .25 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-035 |
| Rexultibrexpiprazole | Brexpiprazole .5 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-036 |
| Rexultibrexpiprazole | Brexpiprazole 1 mg/1 | TabletOral | Otsuka America Pharmaceutical, Inc. | 59148-037 |
| 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. | 59148-042 |
| Rexultibrexpiprazole | Brexpiprazole 2 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3548 |
| Rexultibrexpiprazole | Brexpiprazole 1 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4608 |