mifepristone

Generic: mifepristone

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mifepristone
Generic Name mifepristone
Labeler actavis pharma, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

mifepristone 300 mg/1

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0591-4390
Product ID 0591-4390_57067545-4dd0-4ab0-ba97-d17d74fe7d69
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211436
Listing Expiration 2026-12-31
Marketing Start 2024-01-19

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 05914390
Hyphenated Format 0591-4390

Supplemental Identifiers

RxCUI
1245262
UPC
0305914390965
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 ANDA211436 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 300 mg/1
source: ndc
Packaging
  • 28 TABLET, FILM COATED in 1 BOTTLE (0591-4390-96)
source: ndc

Packages (1)

0591-4390-96 28 TABLET, FILM COATED in 1 BOTTLE (0591-4390-96)

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": "57067545-4dd0-4ab0-ba97-d17d74fe7d69", "openfda": {"nui": ["N0000000115", "N0000175841"], "upc": ["0305914390965"], "unii": ["320T6RNW1F"], "rxcui": ["1245262"], "spl_set_id": ["5e09acc0-fd26-4722-b8b3-46e560390d47"], "pharm_class_epc": ["Progestin Antagonist [EPC]"], "pharm_class_moa": ["Progestational Hormone Receptor Antagonists [MoA]"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28 TABLET, FILM COATED in 1 BOTTLE (0591-4390-96)", "package_ndc": "0591-4390-96", "marketing_start_date": "20240119"}], "brand_name": "Mifepristone", "product_id": "0591-4390_57067545-4dd0-4ab0-ba97-d17d74fe7d69", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Progestational Hormone Receptor Antagonists [MoA]", "Progestin Antagonist [EPC]"], "product_ndc": "0591-4390", "generic_name": "Mifepristone", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mifepristone", "active_ingredients": [{"name": "MIFEPRISTONE", "strength": "300 mg/1"}], "application_number": "ANDA211436", "marketing_category": "ANDA", "marketing_start_date": "20240119", "listing_expiration_date": "20261231"}