Paliperidone
- Product NDC
- 72819-160
- 11-digit product format
- 728190160
- Labeler code
- 72819
- Product ID
- 72819-160_4745a6d1-d9f5-2ff9-e063-6394a90a2825
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- paliperidone
- Dosage form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- Archis Pharma LLC
- Application
- ANDA203802
- Marketing category
- ANDA
- Marketing start
- 2022-04-27
- Substance
- PALIPERIDONE
- Active strength
- 9 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 | 9 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 838F01T721 |
| Rxcui | 672567, 672569, 672571 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 72819-160-03 | Paliperidone | 30 in 1 BOTTLE, PLASTIC | TABLET, FILM COATED, EXTENDED RE | 30 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72819-160 | PALIPERIDONE TABLET, FILM COATED, EXTENDED RELEASE [ARCHIS PHARMA LLC] | 2 | Current NDC, Legacy NDC, 1 package rows | 20230929_e713556e-028e-0f4c-e053-2995a90a9e9f.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 |
|---|
| 72819-160-03 | 72819016003 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (72819-160-03) | 2022-04-27 | 0000-00-00 | No | No | Current |