LACOSAMIDE
- Product NDC
- 70771-1682
- 11-digit product format
- 707711682
- Labeler code
- 70771
- Product ID
- 70771-1682_96b87696-5bfd-4306-b00e-c66e7b93f071
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lacosamide
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Zydus Lifesciences Limited
- Application
- ANDA209465
- Marketing category
- ANDA
- Marketing start
- 2022-06-29
- Substance
- LACOSAMIDE
- Active strength
- 10 mg/mL
- 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 | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 563KS2PQY5 |
| Rxcui | 809974 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70771-1682-1 | LACOSAMIDE | 20 mL in 1 VIAL | INJECTION | 20 | | 2 |
| 70771-1682-6 | LACOSAMIDE | 10 in 1 CARTON | INJECTION | 10 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70771-1682 | LACOSAMIDE INJECTION [ZYDUS LIFESCIENCES LIMITED] | 2 | Current NDC, Legacy NDC, 2 package rows | 20231005_3bc84c70-bc1d-4a72-bbe7-86f32cd646d0.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 |
|---|
| 70771-1682-1 | 70771168201 | 20 mL in 1 VIAL | 20 ml | | | | | Historical |
| 70771-1682-6 | 70771168206 | 10 VIAL in 1 CARTON (70771-1682-6) / 20 mL in 1 VIAL (70771-1682-1) | 10 vial | 2022-06-29 | 0000-00-00 | No | No | Current |