mifepristone

Generic: mifepristone

Labeler: evita solutions llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name mifepristone
Generic Name mifepristone
Labeler evita solutions llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

mifepristone 200 mg/1

Manufacturer
Evita Solutions LLC

Identifiers & Regulatory

Product NDC 84670-014
Product ID 84670-014_4b7d82f9-da40-ce2e-e063-6294a90a92fd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216616
Listing Expiration 2027-12-31
Marketing Start 2025-09-30

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 84670014
Hyphenated Format 84670-014

Supplemental Identifiers

RxCUI
311704
UPC
0384670014018
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 ANDA216616 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 TABLET in 1 BLISTER PACK (84670-014-01)
source: ndc

Packages (1)

84670-014-01 1 TABLET in 1 BLISTER PACK (84670-014-01)

Ingredients (1)

mifepristone (200 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": "4b7d82f9-da40-ce2e-e063-6294a90a92fd", "openfda": {"nui": ["N0000000115", "N0000175841"], "upc": ["0384670014018"], "unii": ["320T6RNW1F"], "rxcui": ["311704"], "spl_set_id": ["839d7a7d-de19-42bd-8810-132b3c2a5daf"], "pharm_class_epc": ["Progestin Antagonist [EPC]"], "pharm_class_moa": ["Progestational Hormone Receptor Antagonists [MoA]"], "manufacturer_name": ["Evita Solutions LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TABLET in 1 BLISTER PACK (84670-014-01)", "package_ndc": "84670-014-01", "marketing_start_date": "20250930"}], "brand_name": "Mifepristone", "product_id": "84670-014_4b7d82f9-da40-ce2e-e063-6294a90a92fd", "dosage_form": "TABLET", "pharm_class": ["Progestational Hormone Receptor Antagonists [MoA]", "Progestin Antagonist [EPC]"], "product_ndc": "84670-014", "generic_name": "MIFEPRISTONE", "labeler_name": "Evita Solutions LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mifepristone", "active_ingredients": [{"name": "MIFEPRISTONE", "strength": "200 mg/1"}], "application_number": "ANDA216616", "marketing_category": "ANDA", "marketing_start_date": "20250930", "listing_expiration_date": "20271231"}