Felbatol
- Product NDC
- 0037-0442
- 11-digit product format
- 000370442
- Labeler code
- 0037
- Product ID
- 0037-0442_1814c148-d0bf-405a-9e20-f3d1aa8c1d9e
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- felbamate
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Meda Pharmaceuticals Inc.
- Application
- NDA020189
- Marketing category
- NDA
- Marketing start
- 1993-07-29
- Marketing end
- 0000-00-00
- Substance
- FELBAMATE
- Active strength
- 600 mg/5mL
- Pharmacologic classes
- Anti-epileptic Agent [EPC], Decreased Central Nervous System Disorganized Electrical Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0037-0442-17 | Felbatol | 946 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 946 | | 16 |
| 0037-0442-67 | Felbatol | 237 mL in 1 BOTTLE, PLASTIC | SUSPENSION | 237 | | 16 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0037-0442 | FELBATOL (FELBAMATE) TABLET FELBATOL (FELBAMATE) SUSPENSION [MEDA PHARMACEUTICALS INC.] | 13 | Legacy NDC, 2 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 |
|---|
| 0037-0442-17 | 00037044217 | 946 mL in 1 BOTTLE, PLASTIC (0037-0442-17) | 946 ml | 1993-07-29 | 0000-00-00 | No | No | Current |
| 0037-0442-67 | 00037044267 | 237 mL in 1 BOTTLE, PLASTIC (0037-0442-67) | 237 ml | 1993-07-29 | 0000-00-00 | No | No | Current |