Felbamate
- Product NDC
- 62559-731
- 11-digit product format
- 625590731
- Labeler code
- 62559
- Product ID
- 62559-731_76100661-b064-4f19-b9ba-8ba4adcf042f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Felbamate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- ANI Pharmaceuticals, Inc.
- Application
- ANDA202284
- Marketing category
- ANDA
- Marketing start
- 2018-09-04
- Substance
- FELBAMATE
- Active strength
- 600 mg/1
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Felbamate
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FELBAMATE | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X72RBB02N8 |
| Rxcui | 198358, 198359 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62559-731-01 | Felbamate | 100 in 1 BOTTLE | TABLET | 100 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62559-731 | FELBAMATE TABLET [ANI PHARMACEUTICALS, INC.] | 4 | Current NDC, Legacy NDC, 1 package rows | 20250206_17850520-f823-4d05-8f9b-5eadfa68bae2.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 |
|---|
| 62559-731-01 | 62559073101 | 100 TABLET in 1 BOTTLE (62559-731-01) | 100 tablet | 2018-09-04 | 0000-00-00 | No | No | Current |