SIMTRIYO
- Product NDC
- 59148-303
- Requested package NDC
- 59148-303-13
- 11-digit product format
- 591480303
- Labeler code
- 59148
- Product ID
- 59148-303_cd3c5560-ab25-4e15-9432-f2c8110f82e9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- centanafadine hydrochloride
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Otsuka America Pharmaceutical, Inc.
- Application
- NDA218145
- Marketing category
- NDA
- Marketing start
- 2026-10-24
- Substance
- CENTANAFADINE HYDROCHLORIDE
- Active strength
- 210 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Source provenance: Browse the complete Orange Book source catalog.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SIMTRIYO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CENTANAFADINE HYDROCHLORIDE | 210 mg/1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 59148-303-13 | 59148030313 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (59148-303-13) | 2026-10-24 | No | No | Current |