INVEGA HAFYERA
- Product NDC
- 50458-611
- 11-digit product format
- 504580611
- Labeler code
- 50458
- Product ID
- 50458-611_2e6ef0e1-19d2-7d78-e063-6394a90ae8a6
- 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
- 2021-08-30
- Substance
- PALIPERIDONE PALMITATE
- Active strength
- 1092 mg/3.5mL
- 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 HAFYERA
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| PALIPERIDONE PALMITATE | 1092 mg/3.5mL |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | R8P8USM8FR |
| Rxcui | 2570418, 2570419, 2570420, 2570421 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3752075e-d817-45ea-9aa1-8dc0301cf2aa | Product name | 1 | 20251114 |
| 893dce58-6330-4a9a-ab03-5ffd7148e184 | Product name | 1 | 20250311 |
| b6847380-b533-d626-e29e-10b60b2ad451 | Product name | 9 | 20250303 |
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| fd328049-536a-4914-b42e-93bf4d93db24 | Product name | 1 | 20220307 |
| 0f0756fc-4d63-4f75-afcc-9c5e62a38d69 | Product name | 2 | 20220304 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50458-611-01 | INVEGA HAFYERA | 1 in 1 CARTON | INJECTION, SUSPENSION, EXTENDED | 1 | 8 | |
| 50458-611-01 | INVEGA HAFYERA | 3.5 mL in 1 SYRINGE | INJECTION, SUSPENSION, EXTENDED | 3.5 | 8 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50458-611-01 | ML - Milliliter | 50458-611 | 4a569866-4663-46f6-90dc-853f022b503d | 1 | 2021-10-08 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2570419 | Invega Hayfera 1092 MG in 3.5 ML Prefilled Syringe | PSN | 6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b | 8 |
| 2570421 | Invega Hayfera 1560 MG in 5 ML Prefilled Syringe | PSN | 6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b | 8 |
| 2570418 | paliperidone palmitate 1092 in 3.5 ML Prefilled Syringe | PSN | 6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b | 8 |
| 2570420 | paliperidone palmitate 1560 MG in 5 ML Prefilled Syringe | PSN | 6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b | 8 |
| 2570419 | 3.5 ML paliperidone palmitate 312 MG/ML Prefilled Syringe [Invega] | SBD | 6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b | 8 |
| 2570421 | 5 ML paliperidone palmitate 312 MG/ML Prefilled Syringe [Invega] | SBD | 6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b | 8 |
| 2570418 | 3.5 ML paliperidone palmitate 312 MG/ML Prefilled Syringe | SCD | 6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b | 8 |
| 2570420 | 5 ML paliperidone palmitate 312 MG/ML Prefilled Syringe | SCD | 6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b | 8 |
| 2570419 | 3.5 ML Invega 312 MG/ML Prefilled Syringe | SY | 6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b | 8 |
| 2570421 | 5 ML Invega 312 MG/ML Prefilled Syringe | SY | 6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b | 8 |
| 2570419 | Invega Hayfera 1092 MG per 3.5 ML Prefilled Syringe | SY | 6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b | 8 |
| 2570421 | Invega Hayfera 1560 MG per 5 ML Prefilled Syringe | SY | 6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b | 8 |
| 2570418 | paliperidone palmitate 1092 per 3.5 ML Prefilled Syringe | SY | 6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b | 8 |
| 2570420 | paliperidone palmitate 1560 MG per 5 ML Prefilled Syringe | SY | 6cd61892-d2cb-434d-83ed-5c1b2c4e7a0b | 8 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50458-611-01 | 50458061101 | 1 SYRINGE in 1 CARTON (50458-611-01) / 3.5 mL in 1 SYRINGE | 1 syringe | 2021-08-30 | 0000-00-00 | No | No | Current |