Felbamate
- Product NDC
- 65162-734
- 11-digit product format
- 651620734
- Labeler code
- 65162
- Product ID
- 65162-734_28bca98d-c89a-492a-a3e5-405098e33919
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Felbamate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amneal Pharmaceuticals LLC
- Application
- ANDA201680
- Marketing category
- ANDA
- Marketing start
- 2011-09-16
- 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 |
|---|
| 65162-734-03 | Felbamate | 30 in 1 BOTTLE | TABLET | 30 | | 12 |
| 65162-734-09 | Felbamate | 90 in 1 BOTTLE | TABLET | 90 | | 12 |
| 65162-734-27 | Felbamate | 270 in 1 BOTTLE | TABLET | 270 | | 12 |
| 65162-734-50 | Felbamate | 500 in 1 BOTTLE | TABLET | 500 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FELBAMATE | ACTIVE INGREDIENT | X72RBB02N8 | FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| FELBAMATE | ACTIVE MOIETY | X72RBB02N8 | FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FELBAMATE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] | 6 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FELBAMATE TABLET [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 |
|---|
| 65162-734 | FELBAMATE TABLET [AMNEAL PHARMACEUTICALS LLC] | 12 | Current NDC, Legacy NDC, 4 package rows | 20241012_aa3fd2c0-98d6-45f3-81b0-a902526214c6.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 |
|---|
| 65162-734-03 | 65162073403 | 30 TABLET in 1 BOTTLE (65162-734-03) | 30 tablet | 2011-09-16 | 0000-00-00 | No | No | Current |
| 65162-734-09 | 65162073409 | 90 TABLET in 1 BOTTLE (65162-734-09) | 90 tablet | 2011-09-16 | 0000-00-00 | No | No | Current |
| 65162-734-27 | 65162073427 | 270 TABLET in 1 BOTTLE (65162-734-27) | 270 tablet | 2011-09-16 | 0000-00-00 | No | No | Current |
| 65162-734-50 | 65162073450 | 500 TABLET in 1 BOTTLE (65162-734-50) | 500 tablet | 2011-09-16 | 0000-00-00 | No | No | Current |