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 NDC11-digit (billing)PackageCopy
13668-745-211366807452120 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 LimitedNDC labeler code 13668
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 220374
Marketing start
Listing expires
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 .

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)

About NDC 13668-745

What is NDC 13668-745?
13668-745 is the product NDC for Fidaxomicin, Fidaxomicin 200 mg/1 tablet, film coated, listed with the FDA by Torrent Pharmaceuticals Limited. 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?
Torrent Pharmaceuticals Limited, NDC labeler code 13668. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
FidaxomicinFidaxomicin 200 mg/1Tablet, Film coatedOralSandoz Inc0781-519400781-5194-20
FidaxomicinFidaxomicin 200 mg/1Tablet, Film coatedOralApotex Corp.60505-483360505-4833-02
FidaxomicinFidaxomicin 200 mg/1Tablet, Film coatedOralTeva Pharmaceuticals, Inc.0480-259600480-2596-34

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