Rexulti
- Product NDC
- 70518-4608
- 11-digit product format
- 705184608
- Labeler code
- 70518
- Product ID
- 70518-4608_5020a0aa-d8a3-5379-e063-6394a90aa65f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- brexpiprazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA205422
- Marketing category
- NDA
- Marketing start
- 2026-04-22
- Substance
- BREXPIPRAZOLE
- Active strength
- 1 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rexulti
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BREXPIPRAZOLE | 1 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2J3YBM1K8C |
| Rxcui | 1658331, 1658333 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4608-0 | Rexulti | 50 in 1 BOX | TABLET | 50 | | 1 |
| 70518-4608-1 | Rexulti | 1 in 1 POUCH | TABLET | 1 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4608-0 | 70518460800 | 50 POUCH in 1 BOX (70518-4608-0) / 1 TABLET in 1 POUCH (70518-4608-1) | 50 pouch | 2026-04-22 | No | No | Current |
| 70518-4608-1 | 70518460801 | 1 in 1 POUCH | | | | | Historical |