Felbamate
- Product NDC
- 53746-734
- 11-digit product format
- 537460734
- Labeler code
- 53746
- Product ID
- 53746-734_b9ac064d-eed2-4d3c-b984-c9ebcef68646
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Felbamate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals of New York LLC
- Application
- ANDA201680
- Marketing category
- ANDA
- Marketing start
- 2022-08-10
- Substance
- FELBAMATE
- Active strength
- 400 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 | 400 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 |
|---|
| 53746-734-30 | Felbamate | 30 in 1 BOTTLE | TABLET | 30 | | 3 |
| 53746-734-90 | Felbamate | 90 in 1 BOTTLE | TABLET | 90 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53746-734 | FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK LLC] | 3 | Current NDC, Legacy NDC, 2 package rows | 20250108_1aa40de5-c02d-49d6-8722-ed88c40c3ba6.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 |
|---|
| 53746-734-30 | 53746073430 | 30 TABLET in 1 BOTTLE (53746-734-30) | 30 tablet | 2022-08-10 | 0000-00-00 | No | No | Current |
| 53746-734-90 | 53746073490 | 90 TABLET in 1 BOTTLE (53746-734-90) | 90 tablet | 2022-08-10 | 0000-00-00 | No | No | Current |