INVEGA TRINZA
- Product NDC
- 50458-609
- 11-digit product format
- 504580609
- Labeler code
- 50458
- Product ID
- 50458-609_2e1c6fa0-3051-4a53-e063-6294a90ad1c3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paliperidone palmitate
- Dosage form
- INJECTION, SUSPENSION, EXTENDED RELEASE
- Route
- INTRAMUSCULAR
- Labeler
- Janssen Pharmaceuticals, Inc
- Application
- NDA207946
- Marketing category
- NDA
- Marketing start
- 2015-05-19
- Substance
- PALIPERIDONE PALMITATE
- Active strength
- 819 mg/2.63mL
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- INVEGA TRINZA
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PALIPERIDONE PALMITATE | 819 mg/2.63mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R8P8USM8FR |
| Rxcui | 1650966, 1650968, 1650971, 1650972, 1650973, 1650974, 1650975, 1650976 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50458-609-01 | INVEGA TRINZA | 1 in 1 KIT | INJECTION, SUSPENSION, EXTENDED | 1 | | 25 |
| 50458-609-01 | INVEGA TRINZA | 1 mL in 1 SYRINGE | INJECTION, SUSPENSION, EXTENDED | 1 | | 25 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| paliperidone palmitate | ACTIVE INGREDIENT | R8P8USM8FR | INVEGA TRINZA (PALIPERIDONE PALMITATE) INJECTION, SUSPENSION, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC] | 1 | |
| paliperidone | ACTIVE MOIETY | 838F01T721 | INVEGA TRINZA (PALIPERIDONE PALMITATE) INJECTION, SUSPENSION, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | INVEGA TRINZA (PALIPERIDONE PALMITATE) INJECTION, SUSPENSION, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC] | 1 | |
| POLYETHYLENE GLYCOL 4000 | INACTIVE INGREDIENT | 4R4HFI6D95 | INVEGA TRINZA (PALIPERIDONE PALMITATE) INJECTION, SUSPENSION, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC] | 1 | |
| POLYSORBATE 20 | INACTIVE INGREDIENT | 7T1F30V5YH | INVEGA TRINZA (PALIPERIDONE PALMITATE) INJECTION, SUSPENSION, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC] | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | INVEGA TRINZA (PALIPERIDONE PALMITATE) INJECTION, SUSPENSION, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | INVEGA TRINZA (PALIPERIDONE PALMITATE) INJECTION, SUSPENSION, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50458-609 | INVEGA TRINZA (PALIPERIDONE PALMITATE) INJECTION, SUSPENSION, EXTENDED RELEASE [JANSSEN PHARMACEUTICALS, INC] | 25 | Current NDC, Legacy NDC, 2 package rows | 20250216_c39e65d7-fa44-4e4c-8b12-a654d3ed0eae.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 50458-609-01 | 50458060901 | 1 SYRINGE in 1 KIT (50458-609-01) / 1 mL in 1 SYRINGE | 1 syringe | 2015-05-19 | 0000-00-00 | No | No | Current |