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

Additional Listing Data#

Finished product
Yes
Brand name base
Mifepristone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MIFEPRISTONE200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii320T6RNW1F
Rxcui311704

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9f80ed59-2511-7c3d-8726-727ad4e34951Product name220210223
d77d5635-fbfa-4e46-b227-bea7fc095975Product name120190710

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84670-014-01Mifepristone1 in 1 BLISTER PACKTABLET15

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311704miFEPRIStone 200 MG Oral TabletPSN839d7a7d-de19-42bd-8810-132b3c2a5daf5
311704mifepristone 200 MG Oral TabletSCD839d7a7d-de19-42bd-8810-132b3c2a5daf5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84670-014-01846700014011 TABLET in 1 BLISTER PACK (84670-014-01) 1 tablet2025-09-30NoNoCurrent