LUMAKRAS
- Product NDC
- 55513-488
- 11-digit product format
- 555130488
- Labeler code
- 55513
- Product ID
- 55513-488_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
- 2021-05-28
- Substance
- SOTORASIB
- Active strength
- 120 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 | 120 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 |
|---|
| 55513-488-01 | LUMAKRAS | 120 in 1 BOTTLE, PLASTIC | TABLET, COATED | 120 | | 19 |
| 55513-488-02 | LUMAKRAS | 2 in 1 CARTON | TABLET, COATED | 2 | | 19 |
| 55513-488-24 | LUMAKRAS | 1 in 1 CARTON | TABLET, COATED | 1 | | 19 |
| 55513-488-40 | LUMAKRAS | 240 in 1 BOTTLE, PLASTIC | TABLET, COATED | 240 | | 19 |
| 55513-488-96 | LUMAKRAS | 120 in 1 BOTTLE, PLASTIC | TABLET, COATED | 120 | | 19 |
| 55513-488-96 | LUMAKRAS | 1 in 1 CARTON | TABLET, COATED | 1 | | 19 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 55513-488 | LUMAKRAS (SOTORASIB) TABLET, COATED [AMGEN INC] | 19 | Current NDC, Legacy NDC, 6 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 | Marketing end | Sample | Exclude flag | Status |
|---|
| 55513-488-01 | 55513048801 | 120 in 1 BOTTLE, PLASTIC | | | | | Historical |
| 55513-488-02 | 55513048802 | 2 BOTTLE, PLASTIC in 1 CARTON (55513-488-02) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-01) | 2021-05-28 | 0000-00-00 | No | No | Current |
| 55513-488-24 | 55513048824 | 1 BOTTLE, PLASTIC in 1 CARTON (55513-488-24) / 240 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-40) | 2021-05-28 | 0000-00-00 | No | No | Current |
| 55513-488-40 | 55513048840 | 240 in 1 BOTTLE, PLASTIC | | | | | Historical |
| 55513-488-96 | 55513048896 | 1 BOTTLE, PLASTIC in 1 CARTON (55513-488-96) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC | 2021-05-28 | 0000-00-00 | Yes | No | Current |