Fycompa
- Product NDC
- 69616-280
- 11-digit product format
- 696160280
- Labeler code
- 69616
- Product ID
- 69616-280_98f5e818-1e3f-43a8-9a56-9c44e639f431
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- perampanel
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Catalyst Pharmaceuticals, Inc.
- Application
- NDA202834
- Marketing category
- NDA
- Marketing start
- 2024-01-02
- 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
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fycompa
- Listing expiration
- 2026-12-31
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, 2641918, 2641919 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69616-280-30 | Fycompa | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 69616-280-90 | Fycompa | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69616-280 | FYCOMPA (PERAMPANEL) TABLET FYCOMPA (PERAMPANEL) SUSPENSION [CATALYST PHARMACEUTICALS, INC.] | 4 | Current NDC, 2 package rows | 20240106_ec812ea3-de3a-4271-957c-db8f692d1ae3.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69616-280-30 | 69616028030 | 30 TABLET in 1 BOTTLE (69616-280-30) | 30 tablet | 2024-01-02 | No | No | Current |
| 69616-280-90 | 69616028090 | 90 TABLET in 1 BOTTLE (69616-280-90) | 90 tablet | 2024-01-02 | No | No | Current |