NDC codes

FDA NDC Directory
Product NDC (as listed)76346-073Labeler and product segments. Claims need a package NDC.
Product NDC at billing width76346-0073Add 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
76346-073-017634600730128 TABLET in 1 BOTTLE (76346-073-01)Marketed from Feb 17, 2012
76346-073-0276346007302280 TABLET in 1 BOTTLE (76346-073-02)Marketed from Feb 17, 2012

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)
Korlym
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 76346-073_f9fd7845-859c-49d4-a1f9-b96b591c4021SPL ID f9fd7845-859c-49d4-a1f9-b96b591c4021SPL set ID 542f3fae-8bc8-4f00-9228-e4b66c9ad6a9RxCUI 1245262, 1245268UNII 320T6RNW1FUPC 0376346073023, 0376346073016
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

N476346007301 followed by a unit qualifier and the quantity

Package 76346-0073-01. 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)

KORLYM (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: KORLYM should not be used in the treatment of patients with type 2 diabetes unless it is secondary to Cushing's syndrome. KORLYM (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 candidat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 202107

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

FDA NDC Directory listings under NDA 202107
ProductStrengthForm · routeLabelerProduct NDC
MifepristoneMifepristone 300 mg/1TabletOralCorcept Therapeutics Incorporated76346-654

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