Prescription drug · NDA
Uloric (Febuxostat) NDC 64764-918
Febuxostat 40 mg/1 · Tablet · Oral · Takeda Pharmaceuticals America, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64764-918-11 | 6476409181164764091811 | 10 BLISTER PACK in 1 CARTON (64764-918-11) / 10 TABLET in 1 BLISTER PACKMarketed from Feb 13, 2009 | |
| 64764-918-18 | 6476409181864764091818 | 500 TABLET in 1 BOTTLE (64764-918-18)Marketed from Feb 13, 2009 | |
| 64764-918-30 | 6476409183064764091830 | 30 TABLET in 1 BOTTLE (64764-918-30)Marketed from Feb 13, 2009 | |
| 64764-918-90 | 6476409189064764091890 | 90 TABLET in 1 BOTTLE (64764-918-90)Marketed from Feb 13, 2009 |
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)
- Uloric
- Generic name (nonproprietary)
- febuxostat
- Active ingredients
- Febuxostat — 40 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Takeda Pharmaceuticals America, Inc.NDC labeler code 64764
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021856
- Marketing start
- Listing expires
- Other FDA classes
- Xanthine Oxidase Inhibitors (Mechanism)
- Identifiers
- Product ID 64764-918_16c36a5a-2f72-4df7-aa6f-1ca27a39404fSPL ID 16c36a5a-2f72-4df7-aa6f-1ca27a39404fSPL set ID 54de10ef-fe5f-4930-b91d-6bbb04c664bdRxCUI 834235, 834239, 834241, 834243UNII 101V0R1N2EUPC 0364764677305
- Pharmacologic class
- Xanthine Oxidase 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
N464764091811followed by a unit qualifier and the quantityPackage 64764-0918-11. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. ULORIC is a xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. ( 1 ) Limitations of Use : ULORIC is not recommended for the treatment of asymptomatic hyperuricemia. ( 1 ) Li…
Excerpt only. Read the full label for complete information.
About NDC 64764-918
- What is NDC 64764-918?
- 64764-918 is the product NDC for Uloric (febuxostat), Febuxostat 40 mg/1 tablet, listed with the FDA by Takeda Pharmaceuticals America, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Uloric (Febuxostat).
- What is the active ingredient?
- Febuxostat.
- Who is the labeler?
- Takeda Pharmaceuticals America, Inc., NDC labeler code 64764. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Uloric?
- 1 other product NDC are listed under this name. See all Uloric NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Uloric products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Uloricfebuxostat | Febuxostat 80 mg/1 | TabletOral | Takeda Pharmaceuticals America, Inc. | 64764-677 | 64764-0677-1164764-0677-1364764-0677-19+1 more |
Other NDCs under NDA 021856
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 |
|---|---|---|---|---|
| Uloricfebuxostat | Febuxostat 80 mg/1 | TabletOral | Takeda Pharmaceuticals America, Inc. | 64764-677 |