Prescription drug · NDA
Ridaura (Auranofin) NDC 54766-093
Auranofin 3 mg/1 · Capsule · Oral · Sebela Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54766-093-06 | 5476600930654766009306 | 60 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
N454766009306followed by a unit qualifier and the quantityPackage 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.
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.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Auranofin | Auranofin 3 mg/1 | CapsuleOral | Coral Way Pharma, LLC | 85437-093 |