paliperidone
- Product NDC
- 46708-804
- 11-digit product format
- 467080804
- Labeler code
- 46708
- Product ID
- 46708-804_be30f3cc-55fb-4a74-9778-60573a7f18c6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paliperidone
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA218330
- Marketing category
- ANDA
- Marketing start
- 2024-09-30
- Substance
- PALIPERIDONE
- Active strength
- 3 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 | 3 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 |
|---|
| 46708-804-30 | paliperidone | 30 in 1 BOTTLE | TABLET, EXTENDED RELEASE | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-804 | PALIPERIDONE TABLET, EXTENDED RELEASE [ALEMBIC PHARMACEUTICALS LIMITED] | 1 | Current NDC, 1 package rows | 20241004_be30f3cc-55fb-4a74-9778-60573a7f18c6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-804-30 | 46708080430 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (46708-804-30) | 2024-09-30 | No | No | Current |