Prescription drug · ANDA
Nitazoxanide NDC 13517-135
Nitazoxanide 500 mg/1 · Tablet · Oral · e5 Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13517-135-06 | 13517013506 | 6 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
N413517013506followed by a unit qualifier and the quantityPackage 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.
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.
Related NDCs: other Nitazoxanide products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| 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 |
| Nitazoxanide | Nitazoxanide 500 mg/1 | Tablet, Film coatedOral | Rising Pharma Holdings, Inc. | 64980-526 | 64980-0526-0364980-0526-2164980-0526-60+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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Nitazoxanide | Nitazoxanide 500 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-934 |