What is NDC 70771-1553?

70771-1553 is the product NDC for febuxostat, Febuxostat 80 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.

Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for febuxostat?

42 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

febuxostat NDC 70771-1553 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70771-1553Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70771-1553Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package
70771-1553-0	7077115530070771155300	1000 TABLET in 1 BOTTLE (70771-1553-0)Marketed from Mar 31, 2023
70771-1553-1	7077115530170771155301	100 TABLET in 1 BOTTLE (70771-1553-1)Marketed from Mar 31, 2023
70771-1553-3	7077115530370771155303	30 TABLET in 1 BOTTLE (70771-1553-3)Marketed from Mar 31, 2023
70771-1553-4	7077115530470771155304	10 BLISTER PACK in 1 CARTON (70771-1553-4) / 10 TABLET in 1 BLISTER PACKMarketed from Mar 31, 2023
70771-1553-5	7077115530570771155305	500 TABLET in 1 BOTTLE (70771-1553-5)Marketed from Mar 31, 2023
70771-1553-9	7077115530970771155309	90 TABLET in 1 BOTTLE (70771-1553-9)Marketed from Mar 31, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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): febuxostat
Generic name (nonproprietary): febuxostat
Active ingredients: Febuxostat — 80 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Zydus Lifesciences LimitedNDC labeler code 70771
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205443
Marketing start: Mar 31, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Xanthine Oxidase Inhibitors (Mechanism)
Identifiers: Product ID 70771-1553_2a9fa82f-de69-4251-8560-5a59d41356b7SPL ID 2a9fa82f-de69-4251-8560-5a59d41356b7SPL set ID 0629ab39-196e-4198-902a-3c16277ba205RxCUI 834235, 834241UNII 101V0R1N2E
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

N470771155300 followed by a unit qualifier and the quantity

Package 70771-1553-00. 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 Aug 16, 2024.

Full label on DailyMed (opens in a new tab)

About NDC 70771-1553

What is NDC 70771-1553?: 70771-1553 is the product NDC for febuxostat, Febuxostat 80 mg/1 tablet, listed with the FDA by Zydus Lifesciences Limited. It has 6 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: febuxostat.
What is the active ingredient?: Febuxostat.
Who is the labeler?: Zydus Lifesciences Limited, NDC labeler code 70771. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for febuxostat?: 42 other product NDCs are listed under this name. See all febuxostat NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other febuxostat NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
febuxostat	Febuxostat 40 mg/1	TabletOral	REMEDYREPACK INC.	70518-4626	70518-4626-00
Febuxostat	Febuxostat 80 mg/1	TabletOral	HEC Pharm USA Inc.	72303-0856	72303-0856-01
Febuxostat	Febuxostat 40 mg/1	TabletOral	HEC Pharm USA Inc.	72303-0855	72303-0855-01
Febuxostat	Febuxostat 40 mg/1	TabletOral	Aurobindo Pharma Limited	59651-113	59651-0113-0559651-0113-3059651-0113-90
Febuxostat	Febuxostat 80 mg/1	TabletOral	Aurobindo Pharma Limited	59651-114	59651-0114-0159651-0114-0559651-0114-30+1 more
Febuxostat	Febuxostat 40 mg/1	TabletOral	Solco Healthcare US LLC	43547-295	43547-0295-0343547-0295-0943547-0295-50
Febuxostat	Febuxostat 80 mg/1	TabletOral	Solco Healthcare US LLC	43547-296	43547-0296-0343547-0296-0943547-0296-50
febuxostat	Febuxostat 40 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1552	70771-1552-0070771-1552-0170771-1552-03+3 more
febuxostat	Febuxostat 40 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-136	72578-0136-0172578-0136-0572578-0136-06+3 more
febuxostat	Febuxostat 80 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-137	72578-0137-0172578-0137-0572578-0137-06+3 more

All 43 febuxostat NDCs

Other NDCs under ANDA 205443

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 205443
Product	Strength	Form · route	Labeler	Product NDC
febuxostat	Febuxostat 40 mg/1	TabletOral	NuCare Pharmaceuticals, Inc.	68071-3760
febuxostat	Febuxostat 40 mg/1	TabletOral	REMEDYREPACK INC.	70518-4626
febuxostat	Febuxostat 40 mg/1	TabletOral	Zydus Lifesciences Limited	70771-1552
febuxostat	Febuxostat 40 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-136
febuxostat	Febuxostat 80 mg/1	TabletOral	Viona Pharmaceuticals Inc	72578-137