ILOPERIDONE
- Product NDC
- 0378-0632
- 11-digit product format
- 003780632
- Labeler code
- 0378
- Product ID
- 0378-0632_30392c6b-2f42-6e82-e063-6394a90a0c88
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- iloperidone
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Mylan Pharmaceuticals Inc.
- Application
- ANDA207231
- Marketing category
- ANDA
- Marketing start
- 2017-03-20
- Substance
- ILOPERIDONE
- Active strength
- 4 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
- ILOPERIDONE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ILOPERIDONE | 4 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | VPO7KJ050N |
| Rxcui | 848722, 848728, 848732, 848736, 848740, 848744, 848748 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0378-0632-01 | ILOPERIDONE | 100 in 1 BOTTLE | TABLET | 100 | | 10 |
| 0378-0632-88 | ILOPERIDONE | 10 in 1 CARTON | TABLET | 10 | | 10 |
| 0378-0632-88 | ILOPERIDONE | 10 in 1 BLISTER PACK | TABLET | 10 | | 10 |
| 0378-0632-91 | ILOPERIDONE | 60 in 1 BOTTLE | TABLET | 60 | | 10 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0378-0632 | ILOPERIDONE TABLET [MYLAN PHARMACEUTICALS INC.] | 10 | Current NDC, Legacy NDC, 4 package rows | 20250316_eeb0fcfd-e4e8-4fb1-9635-901dc9446235.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0378-0632-01 | 00378063201 | 100 TABLET in 1 BOTTLE (0378-0632-01) | 100 tablet | 2017-03-20 | 0000-00-00 | No | No | Current |
| 0378-0632-88 | 00378063288 | 10 BLISTER PACK in 1 CARTON (0378-0632-88) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2017-03-20 | 0000-00-00 | No | No | Current |
| 0378-0632-91 | 00378063291 | 60 TABLET in 1 BOTTLE (0378-0632-91) | 60 tablet | 2017-03-20 | 0000-00-00 | No | No | Current |