PALSONIFY
- Product NDC
- 84015-920
- 11-digit product format
- 840150920
- Labeler code
- 84015
- Product ID
- 84015-920_73db4875-9ff1-4eaf-bc83-0e494aada598
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PALTUSOTINE
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Crinetics Pharmaceuticals, Inc.
- Application
- NDA219070
- Marketing category
- NDA
- Marketing start
- 2025-09-25
- Substance
- PALTUSOTINE HYDROCHLORIDE
- Active strength
- 20 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- PALSONIFY
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PALTUSOTINE HYDROCHLORIDE | 20 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | FZT5Z83JNS |
| Rxcui | 2724403, 2724409, 2724411, 2724413 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 84015-920-60 | PALSONIFY | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 3 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2724409 | Palsonify 20 MG Oral Tablet, Once Daily | PSN | 8a6d2ce0-a621-4ee7-983c-977cd948ff4d | 3 |
| 2724413 | Palsonify 30 MG Oral Tablet, Once Daily | PSN | 8a6d2ce0-a621-4ee7-983c-977cd948ff4d | 3 |
| 2724403 | paltusotine 20 MG Oral Tablet, Once Daily | PSN | 8a6d2ce0-a621-4ee7-983c-977cd948ff4d | 3 |
| 2724411 | paltusotine 30 MG Oral Tablet, Once Daily | PSN | 8a6d2ce0-a621-4ee7-983c-977cd948ff4d | 3 |
| 2724409 | paltusotine 20 MG Oral Tablet [Palsonify] | SBD | 8a6d2ce0-a621-4ee7-983c-977cd948ff4d | 3 |
| 2724413 | paltusotine 30 MG Oral Tablet [Palsonify] | SBD | 8a6d2ce0-a621-4ee7-983c-977cd948ff4d | 3 |
| 2724403 | paltusotine 20 MG Oral Tablet | SCD | 8a6d2ce0-a621-4ee7-983c-977cd948ff4d | 3 |
| 2724411 | paltusotine 30 MG Oral Tablet | SCD | 8a6d2ce0-a621-4ee7-983c-977cd948ff4d | 3 |
| 2724409 | Palsonify 20 MG (equivalent to paltusotine hydrochloride 21.6 MG) Oral Tablet | SY | 8a6d2ce0-a621-4ee7-983c-977cd948ff4d | 3 |
| 2724409 | Palsonify 20 MG Oral Tablet | SY | 8a6d2ce0-a621-4ee7-983c-977cd948ff4d | 3 |
| 2724413 | Palsonify 30 MG (equivalent to paltusotine hydrochloride 32.4 MG) Oral Tablet | SY | 8a6d2ce0-a621-4ee7-983c-977cd948ff4d | 3 |
| 2724413 | Palsonify 30 MG Oral Tablet | SY | 8a6d2ce0-a621-4ee7-983c-977cd948ff4d | 3 |
| 2724403 | paltusotine 20 MG (equivalent to paltusotine hydrochloride 21.6 MG) Oral Tablet | SY | 8a6d2ce0-a621-4ee7-983c-977cd948ff4d | 3 |
| 2724411 | paltusotine 30 MG (equivalent to paltusotine hydrochloride 32.4 MG) Oral Tablet | SY | 8a6d2ce0-a621-4ee7-983c-977cd948ff4d | 3 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|
| 84015-920-60 | 84015092060 | 60 TABLET, FILM COATED in 1 BOTTLE (84015-920-60) | 2025-09-25 | No | No | Current |