Fidaxomicin NDC 13668-745

NDC codes

FDA NDC Directory

Product NDC (as listed)13668-745Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13668-0745Add 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
13668-745-21	13668074521	20 TABLET, FILM COATED in 1 BOTTLE (13668-745-21)Marketed from Jan 27, 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): Fidaxomicin
Generic name (nonproprietary): fidaxomicin
Active ingredients: Fidaxomicin — 200 mg/1
Dosage form: Tablet, Film coated
Route: Oral
Labeler: Torrent Pharmaceuticals Limited
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 220374
Marketing start: Jan 27, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 13668-745_e3cdb249-59e3-41f4-a3c5-efb387ec6d85SPL ID e3cdb249-59e3-41f4-a3c5-efb387ec6d85SPL set ID 8f68f0cb-9573-4d5a-8f31-a93dd2706691RxCUI 1111106UNII Z5N076G8YQUPC 0313668745214
Pharmacologic class: Macrolide Antibacterial

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

N413668074521 followed by a unit qualifier and the quantity

Package 13668-0745-21. 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 Jan 28, 2026.

Indications (excerpt from the label)

Fidaxomicin is a macrolide antibacterial indicated in adult patients for the treatment of C. difficile -associated diarrhea. ( 1.1 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of fidaxomicin tablets and other antibacterial drugs, fidaxomicin tablets should be used only to treat infections that are proven or strongly suspected to be caused by C. difficile . ( 1.2 ) 1.1 Clostridioides difficile- Associated Diarrhea Fidaxomicin tablets are indicated in adult patients for the treatment of C. difficile - associated diarrhea (CDAD). 1.2 Usage To reduce the development of drug-resistant bacteria and maintain the effectiveness of fidaxomicin tablets and other…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)