What is NDC 70564-802?

70564-802 is the product NDC for Mytesi (crofelemer), Crofelemer 125 mg/1 tablet, coated, listed with the FDA by Napo Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Napo Pharmaceuticals, Inc., NDC labeler code 70564. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Mytesi?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Mytesi NDC 70564-802 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70564-802Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70564-0802Add 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	Copy
70564-802-60	70564080260	60 TABLET, COATED in 1 BOTTLE (70564-802-60)Marketed from Aug 1, 2016
70564-802-99	70564080299	60 TABLET, COATED in 1 BOTTLE (70564-802-99)Marketed from Nov 9, 2023 · Sample package

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): Mytesi
Generic name (nonproprietary): crofelemer
Active ingredients: Crofelemer — 125 mg/1
Dosage form: Tablet, Coated
Route: Oral
Labeler: Napo Pharmaceuticals, Inc.NDC labeler code 70564
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 202292
Marketing start: Aug 1, 2016
Listing expires: Dec 31, 2027
Identifiers: Product ID 70564-802_f9b7d7cd-31ef-4030-ae3f-10ab635d0758SPL ID f9b7d7cd-31ef-4030-ae3f-10ab635d0758SPL set ID 45584fba-8081-4cd1-a21e-3ea8237f62ffRxCUI 1364454, 1806878UNII PY79D6C8RXUPC 0370564802601
Pharmacologic class: Antidiarrheal

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

N470564080260 followed by a unit qualifier and the quantity

Package 70564-0802-60. 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 Jul 31, 2026.

Indications (excerpt from the label)

MYTESI is indicated for symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy. MYTESI is an anti-diarrheal indicated for the symptomatic relief of non-infectious diarrhea in adult patients with HIV/AIDS on anti-retroviral therapy. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70564-802

What is NDC 70564-802?: 70564-802 is the product NDC for Mytesi (crofelemer), Crofelemer 125 mg/1 tablet, coated, listed with the FDA by Napo Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Mytesi (Crofelemer).
What is the active ingredient?: Crofelemer.
Who is the labeler?: Napo Pharmaceuticals, Inc., NDC labeler code 70564. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Mytesi?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Mytesi (Crofelemer) NDC 70564-802