FDA.reportPublic FDA data

Ella

Product NDC
50090-5422
11-digit product format
500905422
Labeler code
50090
Product ID
50090-5422_cb78d0c3-de38-40ed-a74b-8391b860e1cb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ulipristal acetate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
NDA022474
Marketing category
NDA
Marketing start
2020-05-11
Substance
ULIPRISTAL ACETATE
Active strength
30 mg/1
Pharmacologic classes
Progesterone Agonist/Antagonist [EPC], Selective Progesterone Receptor Modulators [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ella
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ULIPRISTAL ACETATE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYF7V70N02B
Rxcui1005924, 1005928

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2e4780ec-bddd-4be9-81f2-6de14b4e7739Product name120170504

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5422-02023-02-07C16284748780-1f386c649-bb14-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ella safely and effectively. See full prescribing information for ella. ELLA (ulipristal acetate) tablet, for oral use Initial U.S. Approval: 2010
50090-5422-02023-01-30C16284748780-1f386c649-bb14-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ella safely and effectively. See full prescribing information for ella. ELLA (ulipristal acetate) tablet, for oral use Initial U.S. Approval: 2010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5422-0Ella1 in 1 CARTONTABLET13
50090-5422-0Ella1 in 1 BLISTER PACKTABLET13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5422-0EA - Each50090-5422a1b9eadb-33a9-4110-bacb-10eda9e1f3b912023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5422ELLA (ULIPRISTAL ACETATE) TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20230208_e5f09468-7ac8-40ba-a85b-758a32f586c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1005928Ella 30 MG Oral TabletPSNe5f09468-7ac8-40ba-a85b-758a32f586c33
1005924ulipristal acetate 30 MG Oral TabletPSNe5f09468-7ac8-40ba-a85b-758a32f586c33
1005928ulipristal acetate 30 MG Oral Tablet [Ella]SBDe5f09468-7ac8-40ba-a85b-758a32f586c33
1005924ulipristal acetate 30 MG Oral TabletSCDe5f09468-7ac8-40ba-a85b-758a32f586c33
1005928Ella 30 MG Oral TabletSYe5f09468-7ac8-40ba-a85b-758a32f586c33

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5422-0500905422001 BLISTER PACK in 1 CARTON (50090-5422-0) / 1 TABLET in 1 BLISTER PACK1 blister pack2021-01-060000-00-00NoNoCurrent