Fycompa
- Product NDC
- 62856-280
- 11-digit product format
- 628560280
- Labeler code
- 62856
- Product ID
- 62856-280_57623abc-0527-46c7-9046-4e4d077edbad
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- perampanel
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Eisai Inc.
- Application
- NDA202834
- Marketing category
- NDA
- Marketing start
- 2012-10-22
- Substance
- PERAMPANEL
- Active strength
- 10 mg/1
- Pharmacologic classes
- AMPA Receptor Antagonists [MoA], Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Noncompetitive AMPA Glutamate Receptor Antagonist [EPC], UGT1A9 Inhibitors [MoA], UGT2B7 Inhibitors [MoA]
- DEA schedule
- CIII
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fycompa
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PERAMPANEL | 10 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | H821664NPK |
| Rxcui | 1356557, 1356563, 1356570, 1356572, 1356574, 1356576, 1356578, 1356580, 1356582, 1356584, 1356586, 1356588, 1790122, 1790126 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62856-280-30 | Fycompa | 30 in 1 BOTTLE | TABLET | 30 | | 60 |
| 62856-280-90 | Fycompa | 90 in 1 BOTTLE | TABLET | 90 | | 60 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62856-280 | FYCOMPA (PERAMPANEL) TABLET FYCOMPA (PERAMPANEL) SUSPENSION [EISAI INC.] | 58 | Current NDC, Legacy NDC, 2 package rows | 20231126_71cf3309-e182-473c-8b0b-280cabd0e122.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 |
|---|
| 62856-280-30 | 62856028030 | 30 TABLET in 1 BOTTLE (62856-280-30) | 30 tablet | 2012-10-22 | 0000-00-00 | No | No | Current |
| 62856-280-90 | 62856028090 | 90 TABLET in 1 BOTTLE (62856-280-90) | 90 tablet | 2012-10-22 | 0000-00-00 | No | No | Current |