Prescription drug · NDA
Mifepristone NDC 76346-654
Mifepristone 300 mg/1 · Tablet · Oral · Corcept Therapeutics Incorporated
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76346-654-03 | 76346065403 | 280 TABLET in 1 BOTTLE (76346-654-03)Marketed from May 28, 2024 |
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)
- Mifepristone
- Generic name (nonproprietary)
- mifepristone
- Active ingredients
- Mifepristone — 300 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202107
- Marketing start
- Listing expires
- Other FDA classes
- Progestational Hormone Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 76346-654_4b30c5df-70a3-418c-b2f4-26ab504eb0a3SPL ID 4b30c5df-70a3-418c-b2f4-26ab504eb0a3SPL set ID 63c068cd-9370-460f-829b-70e8c7ebe91eRxCUI 1245262UNII 320T6RNW1FUPC 0376346654031
- Pharmacologic class
- Progestin Antagonist
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
N476346065403followed by a unit qualifier and the quantityPackage 76346-0654-03. 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)
Mifepristone is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surgery. LIMITATIONS OF USE: Mifepristone should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushing's syndrome. Mifepristone is a cortisol receptor blocker indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and have failed surgery or are not candidates for surge…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 202107
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 |
|---|---|---|---|---|
| Korlymmifepristone | Mifepristone 300 mg/1 | TabletOral | Corcept Therapeutics Incorporated | 76346-073 |