What is NDC 0781-5194?

0781-5194 is the product NDC for Fidaxomicin, Fidaxomicin 200 mg/1 tablet, film coated, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fidaxomicin?

3 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fidaxomicin NDC 0781-5194 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-5194Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-5194Add 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
0781-5194-20	00781519420	20 TABLET, FILM COATED in 1 BOTTLE (0781-5194-20)Marketed from Aug 27, 2026

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Sandoz IncNDC labeler code 0781
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 220465
Marketing start: Aug 27, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 0781-5194_5e8ad2f1-a227-4171-9b66-cd6ce49b8baaSPL ID 5e8ad2f1-a227-4171-9b66-cd6ce49b8baaSPL set ID 5e8ad2f1-a227-4171-9b66-cd6ce49b8baaRxCUI 1111106UNII Z5N076G8YQ
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

N400781519420 followed by a unit qualifier and the quantity

Package 00781-5194-20. 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 May 22, 2026.

Indications (excerpt from the label)

Fidaxomicin tablets are 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0781-5194

What is NDC 0781-5194?: 0781-5194 is the product NDC for Fidaxomicin, Fidaxomicin 200 mg/1 tablet, film coated, listed with the FDA by Sandoz Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fidaxomicin.
What is the active ingredient?: Fidaxomicin.
Who is the labeler?: Sandoz Inc, NDC labeler code 0781. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fidaxomicin?: 3 other product NDCs are listed under this name. See all Fidaxomicin 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 Fidaxomicin NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fidaxomicin	Fidaxomicin 200 mg/1	Tablet, Film coatedOral	Apotex Corp.	60505-4833	60505-4833-02
Fidaxomicin	Fidaxomicin 200 mg/1	Tablet, Film coatedOral	Torrent Pharmaceuticals Limited	13668-745	13668-0745-21
Fidaxomicin	Fidaxomicin 200 mg/1	Tablet, Film coatedOral	Teva Pharmaceuticals, Inc.	0480-2596	00480-2596-34