Lacosamide
- Product NDC
- 46708-173
- 11-digit product format
- 467080173
- Labeler code
- 46708
- Product ID
- 46708-173_7dafef1c-ba47-4562-aaa5-671105136aa6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- lacosamide
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Alembic Pharmaceuticals Limited
- Application
- ANDA204974
- Marketing category
- ANDA
- Marketing start
- 2022-03-18
- Substance
- LACOSAMIDE
- Active strength
- 150 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 | 150 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 |
|---|
| 46708-173-10 | Lacosamide | 100 in 1 CARTON | TABLET, FILM COATED | 100 | | 2 |
| 46708-173-30 | Lacosamide | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | | 2 |
| 46708-173-60 | Lacosamide | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | | 2 |
| 46708-173-91 | Lacosamide | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 46708-173 | LACOSAMIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED] | 2 | Current NDC, 4 package rows | 20230129_46b98d5e-fdb6-483a-b022-8b1f0aa832c5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 46708-173-10 | 46708017310 | 100 TABLET, FILM COATED in 1 CARTON (46708-173-10) | 2022-03-18 | No | No | Current |
| 46708-173-30 | 46708017330 | 30 TABLET, FILM COATED in 1 BOTTLE (46708-173-30) | 2022-03-18 | No | No | Current |
| 46708-173-60 | 46708017360 | 60 TABLET, FILM COATED in 1 BOTTLE (46708-173-60) | 2022-03-18 | No | No | Current |
| 46708-173-91 | 46708017391 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-173-91) | 2022-03-18 | No | No | Current |