Lacosamide
- Product NDC
- 47335-980
- 11-digit product format
- 473350980
- Labeler code
- 47335
- Product ID
- 47335-980_506a57ae-8168-44b2-88ef-b9f0e4d0c6b9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lacosamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA205031
- Marketing category
- ANDA
- Marketing start
- 2022-03-19
- Substance
- LACOSAMIDE
- Active strength
- 200 mg/1
- Pharmacologic classes
- Decreased Central Nervous System Disorganized Electrical Activity [PE]
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lacosamide
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LACOSAMIDE | 200 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 563KS2PQY5 |
| Rxcui | 809987, 809992, 809996, 810000 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 47335-980-18 | Lacosamide | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 13 |
| 47335-980-82 | Lacosamide | 180 in 1 BOTTLE | TABLET, FILM COATED | 180 | | 13 |
| 47335-980-86 | Lacosamide | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 13 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 47335-980 | LACOSAMIDE TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] | 13 | Current NDC, Legacy NDC, 3 package rows | 20241017_2098d3a5-776e-4b52-8ade-80a3ab7b3de7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 47335-980-18 | 47335098018 | 1000 TABLET, FILM COATED in 1 BOTTLE (47335-980-18) | 2022-03-19 | 0000-00-00 | No | No | Current |
| 47335-980-82 | 47335098082 | 180 TABLET, FILM COATED in 1 BOTTLE (47335-980-82) | 2022-03-19 | 0000-00-00 | No | No | Current |
| 47335-980-86 | 47335098086 | 60 TABLET, FILM COATED in 1 BOTTLE (47335-980-86) | 2022-03-19 | 0000-00-00 | No | No | Current |