Prescription drug · NDA
Inlyta (Axitinib) NDC 0069-0151
Axitinib 5 mg/1 · Tablet, Film coated · Oral · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-0151-11 | 00069015111 | 60 TABLET, FILM COATED in 1 BOTTLE (0069-0151-11)Marketed from Jan 27, 2012 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Inlyta
- Generic name (nonproprietary)
- axitinib
- Active ingredients
- Axitinib — 5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Pfizer Laboratories Div Pfizer IncNDC labeler code 0069
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202324
- Marketing start
- Listing expires
- Other FDA classes
- Receptor Tyrosine Kinase Inhibitors (Mechanism)
- Identifiers
- Product ID 0069-0151_4382adc1-c177-44e4-988f-3f89ffecb676SPL ID 4382adc1-c177-44e4-988f-3f89ffecb676SPL set ID 84137882-e000-47da-bd5b-fa76ab3c76f9RxCUI 1243004, 1243010, 1243012, 1243014UNII C9LVQ0YUXGUPC 0300690145013, 0300690151113
- Pharmacologic class
- Kinase Inhibitor
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
N400069015111followed by a unit qualifier and the quantityPackage 00069-0151-11. 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)
INLYTA is a kinase inhibitor indicated: • in combination with avelumab, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). ( 1.1 ) • in combination with pembrolizumab, for the first-line treatment of patients with advanced RCC. ( 1.1 ) • as a single agent, for the treatment of advanced renal cell carcinoma (RCC) after failure of one prior systemic therapy. ( 1.2 ) 1.1 First-Line Advanced Renal Cell Carcinoma INLYTA in combination with avelumab is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC). INLYTA in combination with pembrolizumab is indicated for the first-line treatment of patients with advanced RCC. 1.2 Second…
Excerpt only. Read the full label for complete information.
About NDC 0069-0151
- What is NDC 0069-0151?
- 0069-0151 is the product NDC for Inlyta (axitinib), Axitinib 5 mg/1 tablet, film coated, listed with the FDA by Pfizer Laboratories Div Pfizer Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Inlyta (Axitinib).
- What is the active ingredient?
- Axitinib.
- Who is the labeler?
- Pfizer Laboratories Div Pfizer Inc, NDC labeler code 0069. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Inlyta?
- 3 other product NDCs are listed under this name. See all Inlyta NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Inlyta products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Inlytaaxitinib | Axitinib 1 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0145 | 00069-0145-01 |
| Inlytaaxitinib | Axitinib 1 mg/1 | Tablet, Film coatedOral | U.S. Pharmaceuticals | 63539-026 | 63539-0026-01 |
| Inlytaaxitinib | Axitinib 5 mg/1 | Tablet, Film coatedOral | U.S. Pharmaceuticals | 63539-044 | 63539-0044-02 |
Other NDCs under NDA 202324
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 |
|---|---|---|---|---|
| Inlytaaxitinib | Axitinib 1 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-0145 |
| Inlytaaxitinib | Axitinib 1 mg/1 | Tablet, Film coatedOral | U.S. Pharmaceuticals | 63539-026 |
| Inlytaaxitinib | Axitinib 5 mg/1 | Tablet, Film coatedOral | U.S. Pharmaceuticals | 63539-044 |