Prescription drug · NDA
Krazati (adagrasib) NDC 80739-812
Adagrasib 200 mg/1 · Tablet, Coated · Oral · Mirati Therapeutics, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80739-812-12 | 80739081212 | 1 BOTTLE in 1 CARTON (80739-812-12) / 120 TABLET, COATED in 1 BOTTLEMarketed from Dec 12, 2022 | |
| 80739-812-18 | 80739081218 | 1 BOTTLE in 1 CARTON (80739-812-18) / 180 TABLET, COATED in 1 BOTTLEMarketed from Dec 12, 2022 |
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)
- Krazati
- Generic name (nonproprietary)
- adagrasib
- Active ingredients
- Adagrasib — 200 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Mirati Therapeutics, Inc
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216340
- Marketing start
- Listing expires
- Identifiers
- Product ID 80739-812_65724d4c-78ab-4d85-83b5-73b9da5c2cc3SPL ID 65724d4c-78ab-4d85-83b5-73b9da5c2cc3SPL set ID 0b8bf078-34c2-4f45-9012-38a8ac082b01RxCUI 2625917, 2625923UNII 8EOO6HQF8Y
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
N480739081212followed by a unit qualifier and the quantityPackage 80739-0812-12. 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)
KRAZATI is an inhibitor of the RAS GTPase family indicated for: 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 ) Colorectal cancer (CRC)* • In combination with cetuximab, for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic CRC, as determined by an FDA-approved test, who have received prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. ( 1.2 ) *These indications are approved under accelerated approval based on objec…
Excerpt only. Read the full label for complete information.
- openFDA data updated
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