NDC codes

FDA NDC Directory
Product NDC (as listed)13517-135Labeler and product segments. Claims need a package NDC.
Product NDC at billing width13517-0135Add 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 NDC11-digit (billing)PackageCopy
13517-135-06135170135066 TABLET in 1 BOTTLE (13517-135-06)Marketed from Jun 1, 2026

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
Route
Oral
Labeler
e5 Pharma, LLCNDC labeler code 13517
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 214844
Marketing start
Listing expires
Identifiers
Product ID 13517-135_8877f30a-f082-45f8-91f3-7de02b69f50aSPL ID 8877f30a-f082-45f8-91f3-7de02b69f50aSPL set ID 40a7cc30-76cd-49fe-965a-7823c4140d0fRxCUI 427163UNII SOA12P041NUPC 0313517135067
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

N413517013506 followed by a unit qualifier and the quantity

Package 13517-0135-06. 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)

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 tablet is an antiprotozoal indicated for the treatment of diarrhea caused by Giardia lamblia or Cryptosporidium parvum (1). Limitations of Use: Nitazoxanide tablet has not been shown to be effective for the treatment of diarrhea caused by C. parvum in HIV-infect…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 13517-135

What is NDC 13517-135?
13517-135 is the product NDC for Nitazoxanide, Nitazoxanide 500 mg/1 tablet, listed with the FDA by e5 Pharma, LLC. It has 1 package NDC, 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?
e5 Pharma, LLC, NDC labeler code 13517. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
NitazoxanideNitazoxanide 500 mg/1Tablet, Film coatedOralCamber Pharmaceuticals, Inc.31722-10031722-0100-3031722-0100-3131722-0100-32
NitazoxanideNitazoxanide 500 mg/1TabletOralANI Pharmaceuticals, Inc.70954-93470954-0934-10
NitazoxanideNitazoxanide 500 mg/1Tablet, Film coatedOralRising Pharma Holdings, Inc.64980-52664980-0526-0364980-0526-2164980-0526-60+1 more

Other NDCs under ANDA 214844

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

FDA NDC Directory listings under ANDA 214844
ProductStrengthForm · routeLabelerProduct NDC
NitazoxanideNitazoxanide 500 mg/1TabletOralANI Pharmaceuticals, Inc.70954-934

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