What is NDC 0054-0795?

0054-0795 is the product NDC for Fidaxomicin, Fidaxomicin 200 mg/1 tablet, coated, listed with the FDA by Hikma Pharmceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmceuticals USA Inc., NDC labeler code 0054. 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?

4 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 0054-0795 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0795Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0795Add 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
0054-0795-07	0005407950700054079507	20 TABLET, COATED in 1 BOTTLE (0054-0795-07)Marketed from Oct 7, 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, Coated
Route: Oral
Labeler: Hikma Pharmceuticals USA Inc.NDC labeler code 0054
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 219737
Marketing start: Oct 7, 2026
Listing expires: Dec 31, 2027
Other FDA classes: Macrolides (Chemical structure)
Identifiers: Product ID 0054-0795_77be719d-9937-40ab-a73a-b0db15398280SPL ID 77be719d-9937-40ab-a73a-b0db15398280
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

N400054079507 followed by a unit qualifier and the quantity

Package 00054-0795-07. 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 0054-0795

What is NDC 0054-0795?: 0054-0795 is the product NDC for Fidaxomicin, Fidaxomicin 200 mg/1 tablet, coated, listed with the FDA by Hikma Pharmceuticals USA 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?: Hikma Pharmceuticals USA Inc., NDC labeler code 0054. 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?: 4 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	Sandoz Inc	0781-5194	00781-5194-20
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