Prescription drug · NDA
Fruzaqla (Fruquintinib) NDC 63020-225
Fruquintinib 5 mg/1 · Capsule · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63020-225-21 | 6302002252163020022521 | 1 BOTTLE in 1 CARTON (63020-225-21) / 21 CAPSULE in 1 BOTTLEMarketed from Nov 8, 2023 |
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)
- Fruzaqla
- Generic name (nonproprietary)
- fruquintinib
- Active ingredients
- Fruquintinib — 5 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Takeda Pharmaceuticals America, Inc.NDC labeler code 63020
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217564
- Marketing start
- Listing expires
- Identifiers
- Product ID 63020-225_8e86a087-ef8d-424c-8cfe-208bf8d4e122SPL ID 8e86a087-ef8d-424c-8cfe-208bf8d4e122SPL set ID 186d786e-dc8a-45f2-b5e1-01ac0201879fRxCUI 2670184, 2670190, 2670196, 2670198UNII 49DXG3M5ZW
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
N463020022521followed by a unit qualifier and the quantityPackage 63020-0225-21. 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)
1. INDICATIONS AND USAGE FRUZAQLA is indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy. FRUZAQLA is a kinase inhibitor indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine‑, oxaliplatin‑, and irinotecan‑based chemotherapy, an anti‑VEGF therapy, and, if RAS wild‑type and medically appropriate, an anti-EGFR therapy. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 63020-225
- What is NDC 63020-225?
- 63020-225 is the product NDC for Fruzaqla (fruquintinib), Fruquintinib 5 mg/1 capsule, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fruzaqla (Fruquintinib).
- What is the active ingredient?
- Fruquintinib.
- Who is the labeler?
- Takeda Pharmaceuticals America, Inc., NDC labeler code 63020. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Fruzaqla?
- 1 other product NDC are listed under this name. See all Fruzaqla NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Fruzaqla products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Fruzaqlafruquintinib | Fruquintinib 1 mg/1 | CapsuleOral | Takeda Pharmaceuticals America, Inc. | 63020-210 | 63020-0210-21 |
Other NDCs under NDA 217564
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fruzaqlafruquintinib | Fruquintinib 1 mg/1 | CapsuleOral | Takeda Pharmaceuticals America, Inc. | 63020-210 |