Home NDC 84670-014 Mifepristone
Product NDC 84670-014
11-digit product format 846700014
Labeler code 84670
Product ID 84670-014_4b7d82f9-da40-ce2e-e063-6294a90a92fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name MIFEPRISTONE
Dosage form TABLET
Route ORAL
Labeler Evita Solutions LLC
Application ANDA216616
Marketing category ANDA
Marketing start 2025-09-30
Substance MIFEPRISTONE
Active strength 200 mg/1
Pharmacologic classes Progestational Hormone Receptor Antagonists [MoA], Progestin Antagonist [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A216616-001 MIFEPRISTONE MIFEPRISTONE 200MG TABLET / ORAL AB 2025-09-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216616-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A216616-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2025-09-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216616-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2025-09-30 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216616-001 MIFEPRISTONE 200MG TABLET / ORAL AB 2025-09-30 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-02-19 14:30 UTC 2026-02 A216616-001 AB 1 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216616-001 AB 1 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216616-001 AB 1 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Mifepristone
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MIFEPRISTONE 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 320T6RNW1F Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311704 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84670-014-01 Mifepristone 1 in 1 BLISTER PACK TABLET 1 5
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84670-014-01 84670001401 1 TABLET in 1 BLISTER PACK (84670-014-01) 1 tablet 2025-09-30 No No Current