Prescription drug · NDA
Lumakras (Sotorasib) NDC 55513-488
Sotorasib 120 mg/1 · Tablet, Coated · Oral · Amgen Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55513-488-02 | 55513048802 | 2 BOTTLE, PLASTIC in 1 CARTON (55513-488-02) / 120 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-01)Marketed from May 28, 2021 | |
| 55513-488-24 | 55513048824 | 1 BOTTLE, PLASTIC in 1 CARTON (55513-488-24) / 240 TABLET, COATED in 1 BOTTLE, PLASTIC (55513-488-40)Marketed from May 28, 2021 | |
| 55513-488-96 | 55513048896 | 1 BOTTLE, PLASTIC in 1 CARTON (55513-488-96) / 120 TABLET, COATED in 1 BOTTLE, PLASTICMarketed from May 28, 2021 · Sample package |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Lumakras
- Generic name (nonproprietary)
- sotorasib
- Active ingredients
- Sotorasib — 120 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Amgen IncNDC labeler code 55513
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214665
- Marketing start
- Listing expires
- Identifiers
- Product ID 55513-488_8f611e67-8c58-4413-8b81-a200fa7f30e8SPL ID 8f611e67-8c58-4413-8b81-a200fa7f30e8SPL set ID c80a362c-7ac3-4894-a076-0691e68ef8c1RxCUI 2550719, 2550725, 2628240, 2628242, 2687205, 2687207UNII 2B2VM6UC8GUPC 0355513488020, 0000000000000, 0355513488242, 0355513504508
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N455513048802followed by a unit qualifier and the quantityPackage 55513-0488-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
LUMAKRAS is an inhibitor of the RAS GTPase family indicated for: KRAS G12C-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) As a single agent, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy. ( 1.1 ) This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1.1 ) KRAS G12C-mutated Metastatic Colorectal Cancer (mCRC) In combi…
Excerpt only. Read the full label for complete information.
About NDC 55513-488
- What is NDC 55513-488?
- 55513-488 is the product NDC for Lumakras (sotorasib), Sotorasib 120 mg/1 tablet, coated, listed with the FDA by Amgen Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lumakras (Sotorasib).
- What is the active ingredient?
- Sotorasib.
- Who is the labeler?
- Amgen Inc, NDC labeler code 55513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lumakras?
- 2 other product NDCs are listed under this name. See all Lumakras NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lumakras products
Other finished products listed under the same name: strengths, forms and labelers.
Other NDCs under NDA 214665
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.