Paliperidone
- Product NDC
- 0378-3980
- 11-digit product format
- 003783980
- Labeler code
- 0378
- Product ID
- 0378-3980_222509f8-7c2a-404d-b942-e876b7c636ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paliperidone
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA203802
- Marketing category
- ANDA
- Marketing start
- 2015-09-24
- Marketing end
- 2024-04-30
- Substance
- PALIPERIDONE
- Active strength
- 6 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Listing certified through
- 0000-00-00
- 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 |
|---|
| 0378-3980-93 | 00378398093 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-3980-93) | 2015-09-24 | 2024-04-30 | No | No | Current |