Prescription drug · NDA AUTHORIZED GENERIC
Auranofin NDC 85437-093
Auranofin 3 mg/1 · Capsule · Oral · Coral Way Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85437-093-06 | 85437009306 | 60 CAPSULE in 1 BOTTLE (85437-093-06)Marketed from Oct 29, 2025 |
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)
- Auranofin
- Generic name (nonproprietary)
- auranofin
- Active ingredients
- Auranofin — 3 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Coral Way Pharma, LLCNDC labeler code 85437
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 018689
- Marketing start
- Listing expires
- Identifiers
- Product ID 85437-093_42776e01-ac39-5aa4-e063-6294a90a99e9SPL ID 42776e01-ac39-5aa4-e063-6294a90a99e9SPL set ID d688978b-8b91-4377-9f1d-89b805f5747cRxCUI 197386UNII 3H04W2810V
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
N485437009306followed by a unit qualifier and the quantityPackage 85437-0093-06. 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 Auranofin Capsules (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. Auranofin Capsules should be added to a comprehensive baseline program, including non-drug therapies. Unlike anti-inflammatory drugs, Auranofin Capsules 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…
Excerpt only. Read the full label for complete information.
About NDC 85437-093
- What is NDC 85437-093?
- 85437-093 is the product NDC for Auranofin, Auranofin 3 mg/1 capsule, listed with the FDA by Coral Way Pharma, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Auranofin.
- What is the active ingredient?
- Auranofin.
- Who is the labeler?
- Coral Way Pharma, LLC, NDC labeler code 85437. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Auranofin?
- 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 |
|---|---|---|---|---|
| Ridauraauranofin | Auranofin 3 mg/1 | CapsuleOral | Sebela Pharmaceuticals Inc. | 54766-093 |