Paliperidone
- Product NDC
- 70518-4268
- 11-digit product format
- 705184268
- Labeler code
- 70518
- Product ID
- 70518-4268_4018c502-ea5d-80e8-e063-6294a90a1de4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paliperidone
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA205618
- Marketing category
- ANDA
- Marketing start
- 2025-01-27
- 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 | 672569 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-4268-0 | Paliperidone | 30 in 1 BLISTER PACK | TABLET, EXTENDED RELEASE | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-4268 | PALIPERIDONE TABLET, EXTENDED RELEASE [REMEDYREPACK INC.] | 1 | Current NDC, 1 package rows | 20250130_a5492459-e0a2-4c16-9fff-c886e0b4c700.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70518-4268-0 | 70518426800 | 30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (70518-4268-0) | 2025-01-27 | No | No | Historical |