Felbamate
- Product NDC
- 10135-601
- 11-digit product format
- 101350601
- Labeler code
- 10135
- Product ID
- 10135-601_247f89ef-aefa-4eac-bb2c-bc6257880305
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Felbamate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Marlex Pharmaceuticals Inc
- Application
- ANDA201680
- Marketing category
- ANDA
- Marketing start
- 2015-08-01
- Marketing end
- 0000-00-00
- 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
- 2019-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b0edd10c-1754-6637-302d-00e8fb86191c | Product name | 5 | 20190828 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 10135-601-90 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a5df-f424-e053-dadaa90a57ce | Felbamate Tablets |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 10135-601-90 | Felbamate | 90 in 1 BOTTLE | TABLET | 90 | 1 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 10135-601-90 | EA - Each | 10135-601 | 96388b95-a8d1-4ac7-a7e2-df840d3882dc | 1 | 2015-10-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| FELBAMATE | ACTIVE INGREDIENT | X72RBB02N8 | FELBAMATE TABLET [MARLEX PHARMACEUTICALS INC] | 1 | |
| FELBAMATE | ACTIVE MOIETY | X72RBB02N8 | FELBAMATE TABLET [MARLEX PHARMACEUTICALS INC] | 1 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | FELBAMATE TABLET [MARLEX PHARMACEUTICALS INC] | 1 | |
| CROSCARMELLOSE SODIUM | INACTIVE INGREDIENT | M28OL1HH48 | FELBAMATE TABLET [MARLEX PHARMACEUTICALS INC] | 1 | |
| D&C YELLOW NO. 10 | INACTIVE INGREDIENT | 35SW5USQ3G | FELBAMATE TABLET [MARLEX PHARMACEUTICALS INC] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | FELBAMATE TABLET [MARLEX PHARMACEUTICALS INC] | 1 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | FELBAMATE TABLET [MARLEX PHARMACEUTICALS INC] | 1 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | FELBAMATE TABLET [MARLEX PHARMACEUTICALS INC] | 1 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | FELBAMATE TABLET [MARLEX PHARMACEUTICALS INC] | 1 | |
| STARCH, CORN | INACTIVE INGREDIENT | O8232NY3SJ | FELBAMATE TABLET [MARLEX PHARMACEUTICALS INC] | 1 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 198358 | felbamate 400 MG Oral Tablet | PSN | 0a82bcc3-0420-45f5-8c5c-44ab378b4ff3 | 1 |
| 198359 | felbamate 600 MG Oral Tablet | PSN | 0a82bcc3-0420-45f5-8c5c-44ab378b4ff3 | 1 |
| 198358 | felbamate 400 MG Oral Tablet | SCD | 0a82bcc3-0420-45f5-8c5c-44ab378b4ff3 | 1 |
| 198359 | felbamate 600 MG Oral Tablet | SCD | 0a82bcc3-0420-45f5-8c5c-44ab378b4ff3 | 1 |
| 198358 | FELT 400 MG Oral Tablet | SY | 0a82bcc3-0420-45f5-8c5c-44ab378b4ff3 | 1 |
| 198359 | FELT 600 MG Oral Tablet | SY | 0a82bcc3-0420-45f5-8c5c-44ab378b4ff3 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Status |
|---|---|---|---|
| 10135-601-90 | 10135060190 | 90 in 1 BOTTLE | Historical |