LACOSAMIDE
- Product NDC
- 31722-203
- 11-digit product format
- 317220203
- Labeler code
- 31722
- Product ID
- 31722-203_4f6af3bc-4950-4a6e-e063-6294a90a5ef1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- LACOSAMIDE
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Camber Pharmaceuticals, Inc.
- Application
- ANDA216335
- Marketing category
- ANDA
- Marketing start
- 2022-09-14
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LACOSAMIDE
- Listing expiration
- 2027-12-31
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 |
|---|
| 31722-203-20 | LACOSAMIDE | 20 mL in 1 VIAL, GLASS | INJECTION | 20 | | 5 |
| 31722-203-31 | LACOSAMIDE | 10 in 1 CARTON | INJECTION | 10 | | 5 |
| 31722-203-32 | LACOSAMIDE | 20 mL in 1 VIAL, GLASS | INJECTION | 20 | | 5 |
| 31722-203-33 | LACOSAMIDE | 10 in 1 CARTON | INJECTION | 10 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 31722-203 | LACOSAMIDE INJECTION [CAMBER PHARMACEUTICALS, INC.] | 3 | Current NDC, Legacy NDC, 4 package rows | 20231130_e24d3c45-a559-4fca-a7be-74ce37a7066e.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 |
|---|
| 31722-203-20 | 31722020320 | 10 VIAL, GLASS in 1 CARTON (31722-203-20) > 20 mL in 1 VIAL, GLASS (31722-203-31) | | 2022-09-14 | 0000-00-00 | No | No | Current |
| 31722-203-31 | 31722020331 | 10 VIAL, GLASS in 1 CARTON (31722-203-31) / 20 mL in 1 VIAL, GLASS (31722-203-20) | | 2022-09-14 | | No | No | Historical |
| 31722-203-32 | 31722020332 | 20 mL in 1 VIAL, GLASS | 20 ml | | | | | Historical |
| 31722-203-33 | 31722020333 | 10 VIAL, GLASS in 1 CARTON (31722-203-33) / 20 mL in 1 VIAL, GLASS (31722-203-32) | | 2022-09-14 | | No | No | Historical |