LUMAKRAS
- Product NDC
- 55513-512
- 11-digit product format
- 555130512
- Labeler code
- 55513
- Product ID
- 55513-512_8f611e67-8c58-4413-8b81-a200fa7f30e8
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sotorasib
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- Amgen Inc
- Application
- NDA214665
- Marketing category
- NDA
- Marketing start
- 2024-06-27
- Substance
- SOTORASIB
- Active strength
- 240 mg/1
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- LUMAKRAS
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SOTORASIB | 240 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2B2VM6UC8G |
| Rxcui | 2550719, 2550725, 2628240, 2628242, 2687205, 2687207 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 55513-512-60 | LUMAKRAS | 1 in 1 CARTON | TABLET, COATED | 1 | | 19 |
| 55513-512-60 | LUMAKRAS | 120 in 1 BOTTLE, PLASTIC | TABLET, COATED | 120 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55513-512 | LUMAKRAS (SOTORASIB) TABLET, COATED [AMGEN INC] | 19 | Current NDC, 2 package rows | 20250130_c80a362c-7ac3-4894-a076-0691e68ef8c1.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 55513-512-60 | 55513051260 | 1 BOTTLE, PLASTIC in 1 CARTON (55513-512-60) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC | 2024-06-27 | No | No | Historical |