Paliperidone
- Product NDC
- 16714-869
- 11-digit product format
- 167140869
- Labeler code
- 16714
- Product ID
- 16714-869_d8ce0982-0101-48f6-a85c-8b2c8c8fd0d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paliperidone
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- NorthStar RxLLC
- Application
- ANDA205618
- Marketing category
- ANDA
- Marketing start
- 2018-10-15
- 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 |
|---|
| 16714-869-01 | Paliperidone | 30 in 1 BOTTLE | TABLET, FILM COATED, EXTENDED RE | 30 | | 8 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16714-869 | PALIPERIDONE TABLET, EXTENDED RELEASE [NORTHSTAR RXLLC] | 7 | Current NDC, Legacy NDC, 1 package rows | 20250402_5589ec69-c49c-44a7-9561-bbffeb918d1f.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 |
|---|
| 16714-869-01 | 16714086901 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (16714-869-01) | 2018-10-15 | 0000-00-00 | No | No | Current |