Felbatol
- Product NDC
- 0037-0430
- 11-digit product format
- 000370430
- Labeler code
- 0037
- Product ID
- 0037-0430_374f8c69-4219-47fd-aeda-8edc73da5411
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- felbamate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Viatris Specialty LLC
- Application
- NDA020189
- Marketing category
- NDA
- Marketing start
- 1993-07-29
- 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
- Felbatol
- 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, 209026, 209027, 209028, 310285 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0037-0430-01 | Felbatol | 100 in 1 BOTTLE, PLASTIC | TABLET | 100 | | 16 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0037-0430 | FELBATOL (FELBAMATE) TABLET FELBATOL (FELBAMATE) SUSPENSION [MEDA PHARMACEUTICALS INC.] | 13 | Current NDC, Legacy NDC, 1 package rows | 20241013_2f522701-397a-11de-8a39-0800200c9a66.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 |
|---|
| 0037-0430-01 | 00037043001 | 100 TABLET in 1 BOTTLE, PLASTIC (0037-0430-01) | 100 tablet | 1993-07-29 | 0000-00-00 | No | No | Current |