Felbamate
- Product NDC
- 70771-1078
- 11-digit product format
- 707711078
- Labeler code
- 70771
- Product ID
- 70771-1078_785f1747-e29d-432a-82e7-fcaeea202327
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Felbamate
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA208970
- Marketing category
- ANDA
- Marketing start
- 2017-08-15
- Substance
- FELBAMATE
- Active strength
- 600 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 | 600 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | X72RBB02N8 |
| Rxcui | 198358, 198359 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1078 | FELBAMATE TABLET [ZYDUS LIFESCIENCES LIMITED] | 6 | Current NDC, Legacy NDC, 7 package rows | 20240821_efa55cb2-b625-4392-9ddb-0a8ad8ee58c4.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 |
|---|
| 70771-1078-1 | 70771107801 | 100 TABLET in 1 BOTTLE (70771-1078-1) | 100 tablet | 2017-08-15 | 0000-00-00 | No | No | Current |
| 70771-1078-3 | 70771107803 | 30 TABLET in 1 BOTTLE (70771-1078-3) | 30 tablet | 2017-08-15 | 0000-00-00 | No | No | Current |
| 70771-1078-4 | 70771107804 | 10 BLISTER PACK in 1 CARTON (70771-1078-4) / 10 TABLET in 1 BLISTER PACK | 10 blister pack | 2017-08-15 | 0000-00-00 | No | No | Current |
| 70771-1078-5 | 70771107805 | 500 TABLET in 1 BOTTLE (70771-1078-5) | 500 tablet | 2017-08-15 | 0000-00-00 | No | No | Current |
| 70771-1078-8 | 70771107808 | 180 TABLET in 1 BOTTLE (70771-1078-8) | 180 tablet | 2017-08-15 | 0000-00-00 | No | No | Current |
| 70771-1078-9 | 70771107809 | 90 TABLET in 1 BOTTLE (70771-1078-9) | 90 tablet | 2017-08-15 | 0000-00-00 | No | No | Current |