Paliperidone
- Product NDC
- 0591-3695
- 11-digit product format
- 005913695
- Labeler code
- 0591
- Product ID
- 0591-3695_b168851f-ad1b-4391-857e-805f3b645711
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Paliperidone
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Actavis Pharma, Inc.
- Application
- ANDA202645
- Marketing category
- ANDA
- Marketing start
- 2015-09-24
- Marketing end
- 0000-00-00
- Substance
- PALIPERIDONE
- Active strength
- 9 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0591-3695-10 | 00591369510 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3695-10) | 2015-09-24 | 0000-00-00 | No | No | Current |
| 0591-3695-19 | 00591369519 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3695-19) | 2015-09-24 | 0000-00-00 | No | No | Current |
| 0591-3695-30 | 00591369530 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0591-3695-30) | 2015-09-24 | 0000-00-00 | No | No | Current |