What is NDC 64980-526?

64980-526 is the product NDC for Nitazoxanide, Nitazoxanide 500 mg/1 tablet, film coated, listed with the FDA by Rising Pharma Holdings, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 64980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Nitazoxanide?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Nitazoxanide NDC 64980-526 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)64980-526Labeler and product segments. Claims need a package NDC.

Product NDC at billing width64980-0526Add 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
64980-526-03	64980052603	30 TABLET, FILM COATED in 1 BOTTLE (64980-526-03)Marketed from Nov 27, 2020
64980-526-21	64980052621	12 TABLET, FILM COATED in 1 BOTTLE (64980-526-21)Marketed from Nov 27, 2020
64980-526-60	64980052660	6 TABLET, FILM COATED in 1 BOTTLE (64980-526-60)Marketed from Nov 27, 2020
64980-526-81	64980052681	18 TABLET, FILM COATED in 1 BOTTLE (64980-526-81)Marketed from Nov 27, 2020

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): Nitazoxanide
Generic name (nonproprietary): nitazoxanide
Active ingredients: Nitazoxanide — 500 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Rising Pharma Holdings, Inc.NDC labeler code 64980
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213820
Marketing start: Nov 27, 2020
Listing expires: Dec 31, 2026
Identifiers: Product ID 64980-526_9ee8087a-d001-42a9-ae98-6e4cbf93caa1SPL ID 9ee8087a-d001-42a9-ae98-6e4cbf93caa1SPL set ID c0dc0656-3c46-43f9-adea-5285c522cef8RxCUI 427163UNII SOA12P041NUPC 0364980526036
Pharmacologic class: Antiprotozoal

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

N464980052603 followed by a unit qualifier and the quantity

Package 64980-0526-03. 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 Oct 9, 2025.

Indications (excerpt from the label)

Diarrhea caused by Giardia lamblia or Cryptosporidium parvum: Nitazoxanide tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum. Limitations of Use Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by Cryptosporidium parvum in HIV-infected or immunodeficient patients [see Clinical Studies (14.2) ]. Nitazoxanide tablets are antiprotozoal indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum (1). Limitations of Use: Nitazoxanide tablets have not been shown to be effective for the treatment of diarrhea caused by C. parvum in HIV-infec…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 64980-526

What is NDC 64980-526?: 64980-526 is the product NDC for Nitazoxanide, Nitazoxanide 500 mg/1 tablet, film coated, listed with the FDA by Rising Pharma Holdings, Inc.. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Nitazoxanide.
What is the active ingredient?: Nitazoxanide.
Who is the labeler?: Rising Pharma Holdings, Inc., NDC labeler code 64980. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Nitazoxanide?: 3 other product NDCs are listed under this name. See all Nitazoxanide 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 Nitazoxanide NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Nitazoxanide	Nitazoxanide 500 mg/1	TabletOral	e5 Pharma, LLC	13517-135	13517-0135-06
Nitazoxanide	Nitazoxanide 500 mg/1	Tablet, Film coatedOral	Camber Pharmaceuticals, Inc.	31722-100	31722-0100-3031722-0100-3131722-0100-32
Nitazoxanide	Nitazoxanide 500 mg/1	TabletOral	ANI Pharmaceuticals, Inc.	70954-934	70954-0934-10