mifepristone

Generic: mifepristone

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

Drug Facts

Product Profile

Brand Name mifepristone
Generic Name mifepristone
Labeler genbiopro, inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

mifepristone 200 mg/1

Manufacturer
GenBioPro, Inc.

Identifiers & Regulatory

Product NDC 43393-001
Product ID 43393-001_38fb9b4e-422b-35d9-e063-6394a90a8300
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091178
Listing Expiration 2026-12-31
Marketing Start 2019-05-01

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 43393001
Hyphenated Format 43393-001

Supplemental Identifiers

RxCUI
311704
UPC
0343393001019 0343393001064
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 ANDA091178 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 6 CARTON in 1 PACKAGE (43393-001-06) / 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (43393-001-01)
source: ndc

Packages (1)

43393-001-06 6 CARTON in 1 PACKAGE (43393-001-06) / 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (43393-001-01)

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": "38fb9b4e-422b-35d9-e063-6394a90a8300", "openfda": {"nui": ["N0000000115", "N0000175841"], "upc": ["0343393001019", "0343393001064"], "unii": ["320T6RNW1F"], "rxcui": ["311704"], "spl_set_id": ["b63fad9b-7f12-4400-9019-b0586054e534"], "pharm_class_epc": ["Progestin Antagonist [EPC]"], "pharm_class_moa": ["Progestational Hormone Receptor Antagonists [MoA]"], "manufacturer_name": ["GenBioPro, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 CARTON in 1 PACKAGE (43393-001-06)  / 1 BLISTER PACK in 1 CARTON / 1 TABLET in 1 BLISTER PACK (43393-001-01)", "package_ndc": "43393-001-06", "marketing_start_date": "20190501"}], "brand_name": "Mifepristone", "product_id": "43393-001_38fb9b4e-422b-35d9-e063-6394a90a8300", "dosage_form": "TABLET", "pharm_class": ["Progestational Hormone Receptor Antagonists [MoA]", "Progestin Antagonist [EPC]"], "product_ndc": "43393-001", "generic_name": "MIFEPRISTONE", "labeler_name": "GenBioPro, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Mifepristone", "active_ingredients": [{"name": "MIFEPRISTONE", "strength": "200 mg/1"}], "application_number": "ANDA091178", "marketing_category": "ANDA", "marketing_start_date": "20190501", "listing_expiration_date": "20261231"}