Prescription drug · ANDA
Mifepristone NDC 0591-4390
Mifepristone 300 mg/1 · Tablet, Film coated · Oral · Actavis Pharma, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0591-4390-96 | 00591439096 | 28 TABLET, FILM COATED in 1 BOTTLE (0591-4390-96)Marketed from Jan 19, 2024 |
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)
- Mifepristone
- Generic name (nonproprietary)
- mifepristone
- Active ingredients
- Mifepristone — 300 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Actavis Pharma, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211436
- Marketing start
- Listing expires
- Other FDA classes
- Progestational Hormone Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0591-4390_57067545-4dd0-4ab0-ba97-d17d74fe7d69SPL ID 57067545-4dd0-4ab0-ba97-d17d74fe7d69SPL set ID 5e09acc0-fd26-4722-b8b3-46e560390d47RxCUI 1245262UNII 320T6RNW1FUPC 0305914390965
- 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
N400591439096followed by a unit qualifier and the quantityPackage 00591-4390-96. 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 tablets 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 f…
Excerpt only. Read the full label for complete information.