NDC codes

FDA NDC Directory
Product NDC (as listed)54766-093Labeler and product segments. Claims need a package NDC.
Product NDC at billing width54766-0093Add 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
54766-093-06547660093065476600930660 CAPSULE in 1 BOTTLE (54766-093-06)Marketed from Dec 15, 2016

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)
Ridaura
Generic name (nonproprietary)
auranofin
Active ingredients
Auranofin — 3 mg/1
Dosage form
Capsule
Route
Oral
Labeler
Sebela Pharmaceuticals Inc.NDC labeler code 54766
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 018689
Marketing start
Marketing end
Identifiers
Product ID 54766-093_431445cb-3625-82d8-e063-6394a90aeaeaSPL ID 431445cb-3625-82d8-e063-6394a90aeaeaSPL set ID 43ba3de1-ab2e-06f6-e054-00144ff8d46cRxCUI 197386, 213510UNII 3H04W2810VUPC 0354766093067

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

N454766009306 followed by a unit qualifier and the quantity

Package 54766-0093-06. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE RIDAURA (auranofin) is indicated in the management of adults with active classical or definite rheumatoid arthritis (ARA criteria) who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of full doses of one or more nonsteroidal anti-inflammatory drugs. RIDAURA should be added to a comprehensive baseline program, including non-drug therapies. Unlike anti-inflammatory drugs, RIDAURA does not produce an immediate response. Therapeutic effects may be seen after three to four months of treatment, although improvement has not been seen in some patients before six months. When cartilage and bone damage has already occurred, gold cannot re…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 54766-093

What is NDC 54766-093?
54766-093 is the product NDC for Ridaura (auranofin), Auranofin 3 mg/1 capsule, listed with the FDA by Sebela Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ridaura (Auranofin).
What is the active ingredient?
Auranofin.
Who is the labeler?
Sebela Pharmaceuticals Inc., NDC labeler code 54766. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ridaura?
None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under NDA 018689

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 018689
ProductStrengthForm · routeLabelerProduct NDC
AuranofinAuranofin 3 mg/1CapsuleOralCoral Way Pharma, LLC85437-093

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