PALIPERIDONE
- Product NDC
- 43975-351
- 11-digit product format
- 439750351
- Labeler code
- 43975
- Product ID
- 43975-351_338098af-3cc9-1639-e063-6394a90a6550
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- PALIPERIDONE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA204452
- Marketing category
- ANDA
- Marketing start
- 2019-11-27
- Substance
- PALIPERIDONE
- Active strength
- 6 mg/1
- 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
- PALIPERIDONE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PALIPERIDONE | 6 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 |
|---|
| 43975-351-03 | PALIPERIDONE | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43975-351 | PALIPERIDONE TABLET, EXTENDED RELEASE [ANI PHARMACEUTICALS, INC.] | 7 | Current NDC, Legacy NDC, 1 package rows | 20250426_bbbaa057-f587-4eb9-a0d2-463dbcd57661.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43975-351-03 | 43975035103 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43975-351-03) | 2019-11-27 | 0000-00-00 | No | No | Current |