Felbamate
- Product NDC
- 65162-686
- 11-digit product format
- 651620686
- Labeler code
- 65162
- Product ID
- 65162-686_5ae2c0c1-5f34-4c23-bb17-169302c2253f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Felbamate
- Dosage form
- SUSPENSION
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA202385
- Marketing category
- ANDA
- Marketing start
- 2011-12-16
- 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
- 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/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X72RBB02N8 |
| Rxcui | 310285 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65162-686-88 | Felbamate | 237 mL in 1 BOTTLE | SUSPENSION | 237 | | 14 |
| 65162-686-90 | Felbamate | 473 mL in 1 BOTTLE | SUSPENSION | 473 | | 14 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FELBAMATE | ACTIVE INGREDIENT | X72RBB02N8 | FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| FELBAMATE | ACTIVE MOIETY | X72RBB02N8 | FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| CARBOXYMETHYLCELLULOSE SODIUM | INACTIVE INGREDIENT | K679OBS311 | FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65162-686 | FELBAMATE SUSPENSION [AMNEAL PHARMACEUTICALS LLC] | 14 | Current NDC, Legacy NDC, 2 package rows | 20241027_2e325d79-d0a4-4af7-b09b-96ee5a5b2a37.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 |
|---|
| 65162-686-88 | 65162068688 | 237 mL in 1 BOTTLE (65162-686-88) | 237 ml | 2011-12-16 | 0000-00-00 | No | No | Current |
| 65162-686-90 | 65162068690 | 473 mL in 1 BOTTLE (65162-686-90) | 473 ml | 2011-12-16 | 0000-00-00 | No | No | Current |