PALIPERIDONE
- Product NDC
- 31722-320
- 11-digit product format
- 317220320
- Labeler code
- 31722
- Product ID
- 31722-320_a6b46674-2b24-4485-9d9f-7f4bcfb20ae3
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paliperidone
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Camber Pharmaceuticals, Inc
- Application
- ANDA216174
- Marketing category
- ANDA
- Marketing start
- 2023-08-23
- Substance
- PALIPERIDONE
- Active strength
- 9 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
- PALIPERIDONE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PALIPERIDONE | 9 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 838F01T721 |
| Rxcui | 672567, 672569, 672571, 866103 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 31722-320-30 | PALIPERIDONE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-320 | PALIPERIDONE TABLET, EXTENDED RELEASE [CAMBER PHARMACEUTICALS, INC] | 1 | Current NDC, 1 package rows | 20240328_1cfcad42-da71-457d-b1e1-aee806642d0c.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 31722-320-30 | 31722032030 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (31722-320-30) | 2023-08-23 | No | No | Current |