mifepristone

Generic: mifepristone

Labeler: corcept therapeutics incorporated
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name mifepristone
Generic Name mifepristone
Labeler corcept therapeutics incorporated
Dosage Form TABLET
Routes
ORAL
Active Ingredients

mifepristone 300 mg/1

Manufacturer
Corcept Therapeutics Incorporated

Identifiers & Regulatory

Product NDC 76346-654
Product ID 76346-654_4b30c5df-70a3-418c-b2f4-26ab504eb0a3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA202107
Listing Expiration 2026-12-31
Marketing Start 2024-05-28

Pharmacologic Class

Established (EPC)
progestin antagonist [epc]
Mechanism of Action
progestational hormone receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76346654
Hyphenated Format 76346-654

Supplemental Identifiers

RxCUI
1245262
UPC
0376346654031
UNII
320T6RNW1F
NUI
N0000000115 N0000175841

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name mifepristone (source: ndc)
Generic Name mifepristone (source: ndc)
Application Number NDA202107 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 280 TABLET in 1 BOTTLE (76346-654-03)
source: ndc

Packages (1)

76346-654-03 280 TABLET in 1 BOTTLE (76346-654-03)

Ingredients (1)

mifepristone (300 mg/1)

Linked Drug Pages (1)

Mifepristone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4b30c5df-70a3-418c-b2f4-26ab504eb0a3", "openfda": {"nui": ["N0000000115", "N0000175841"], "upc": ["0376346654031"], "unii": ["320T6RNW1F"], "rxcui": ["1245262"], "spl_set_id": ["63c068cd-9370-460f-829b-70e8c7ebe91e"], "pharm_class_epc": ["Progestin Antagonist [EPC]"], "pharm_class_moa": ["Progestational Hormone Receptor Antagonists [MoA]"], "manufacturer_name": ["Corcept Therapeutics Incorporated"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "280 TABLET in 1 BOTTLE (76346-654-03)", "package_ndc": "76346-654-03", "marketing_start_date": "20240528"}], "brand_name": "Mifepristone", "product_id": "76346-654_4b30c5df-70a3-418c-b2f4-26ab504eb0a3", "dosage_form": "TABLET", "pharm_class": ["Progestational Hormone Receptor Antagonists [MoA]", "Progestin Antagonist [EPC]"], "product_ndc": "76346-654", "generic_name": "Mifepristone", "labeler_name": "Corcept Therapeutics Incorporated", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mifepristone", "active_ingredients": [{"name": "MIFEPRISTONE", "strength": "300 mg/1"}], "application_number": "NDA202107", "marketing_category": "NDA", "marketing_start_date": "20240528", "listing_expiration_date": "20261231"}