NDC codes

FDA NDC Directory
Product NDC (as listed)0480-2596Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00480-2596Add 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
0480-2596-340048025963420 TABLET, FILM COATED in 1 BOTTLE (0480-2596-34)Marketed from Jul 15, 2025

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
Teva Pharmaceuticals, Inc.NDC labeler code 0480
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 208443
Marketing start
Listing expires
Other FDA classes
Macrolides (Chemical structure)
Identifiers
Product ID 0480-2596_2b91a4ed-fd17-4794-ab84-877d8ad45f48SPL ID 2b91a4ed-fd17-4794-ab84-877d8ad45f48
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

N400480259634 followed by a unit qualifier and the quantity

Package 00480-2596-34. 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

The FDA listing for this product does not reference a label (SPL) set.

About NDC 0480-2596

What is NDC 0480-2596?
0480-2596 is the product NDC for Fidaxomicin, Fidaxomicin 200 mg/1 tablet, film coated, listed with the FDA by Teva Pharmaceuticals, 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?
Teva Pharmaceuticals, Inc., NDC labeler code 0480. 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 coatedOralTorrent Pharmaceuticals Limited13668-74513668-0745-21

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