Rexulti
- Product NDC
- 70518-3548
- 11-digit product format
- 705183548
- Labeler code
- 70518
- Product ID
- 70518-3548_502002a4-924a-5370-e063-6394a90a9717
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- brexpiprazole
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- NDA205422
- Marketing category
- NDA
- Marketing start
- 2022-10-03
- Substance
- BREXPIPRAZOLE
- Active strength
- 2 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 | 2 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2J3YBM1K8C |
| Rxcui | 1658335, 1658337 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3548-0 | 70518354800 | 1 BOTTLE in 1 CARTON (70518-3548-0) > 30 TABLET in 1 BOTTLE | 1 bottle | 2022-10-03 | 0000-00-00 | No | No | Current |
| 70518-3548-1 | 70518354801 | 50 POUCH in 1 BOX (70518-3548-1) / 1 TABLET in 1 POUCH (70518-3548-2) | 50 pouch | 2026-04-22 | | No | No | Current |
| 70518-3548-2 | 70518354802 | 1 in 1 POUCH | | | | | | Historical |