NDC 50090-5422-00 - Ella

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC: 50090-5422
Requested NDC: 50090-5422-00
Package NDCs from labels: 50090-5422-0, 50090-5422-00
Manufacturer: A-S Medication Solutions
Effective date: 2023-02-06
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Ella - A-S Medication Solutions	A-S Medication Solutions	2023-02-06	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5422-0	2023-02-07	C162847	48780-1	f386c649-bb14-0266-e053-dadaa90a7c1a	These 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
50090-5422-0	2023-01-30	C162847	48780-1	f386c649-bb14-0266-e053-dadaa90a7c1a	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-5422-0	Ella	1 in 1 CARTON	TABLET	1		3
50090-5422-0	Ella	1 in 1 BLISTER PACK	TABLET	1		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5422	ELLA (ULIPRISTAL ACETATE) TABLET [A-S MEDICATION SOLUTIONS]	3	Current NDC, Legacy NDC, 2 package rows	20230208_e5f09468-7ac8-40ba-a85b-758a32f586c3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5422-0	EA - Each	50090-5422	a1b9eadb-33a9-4110-bacb-10eda9e1f3b9	1	2023-03-13

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ella	ULIPRISTAL ACETATE	PMI Branded Pharmaceuticals, Inc.	2bf93d23-cddd-4613-9066-5b5fa090404b	2026-07-20	Warnings, Adverse reactions	Exact identifier application number: NDA022474 ndc (product): 73302-456 rxcui: 1005924 rxcui: 1005928 spl id: 30e0d760-1e27-456f-8420-ad1c219f49f7 spl set id: 2bf93d23-cddd-4613-9066-5b5fa090404b unii: YF7V70N02B
Ella	ULIPRISTAL ACETATE	A-S Medication Solutions	e5f09468-7ac8-40ba-a85b-758a32f586c3	2023-02-06	Warnings, Adverse reactions	Exact identifier application number: NDA022474 ndc (package): 50090-5422-0 ndc (product): 50090-5422 ndc11 (package): 50090542200 rxcui: 1005924 rxcui: 1005928 spl id: cb78d0c3-de38-40ed-a74b-8391b860e1cb spl set id: e5f09468-7ac8-40ba-a85b-758a32f586c3 unii: YF7V70N02B

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.