Ella

Product NDC: 53002-1630
11-digit product format: 530021630
Labeler code: 53002
Product ID: 53002-1630_0a889280-cfaa-4bba-aa2a-35c0d1dfc00d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ulipristal acetate
Dosage form: TABLET
Route: ORAL
Labeler: RPK Pharmaceuticals, Inc.
Application: NDA022474
Marketing category: NDA
Marketing start: 2010-08-13
Marketing end: 0000-00-00
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: 2021-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
2e4780ec-bddd-4be9-81f2-6de14b4e7739	Product name	1	20170504

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53002-1630-1	2023-01-30	C162847	48780-1	9d75b9cf-f143-f424-e053-dadaa90a57ce	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
53002-1630-1	2020-12-15	C162847	48780-1	9d75b9cf-f143-f424-e053-dadaa90a57ce	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
53002-1630-1	2020-01-31	C162847	48780-1	9d75b9cf-f143-f424-e053-dadaa90a57ce	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

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53002-1630-1	Ella	1 in 1 DOSE PACK	TABLET	1		5

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53002-1630	ELLA (ULIPRISTAL ACETATE) TABLET [RPK PHARMACEUTICALS, INC.]	5	Legacy NDC, 1 package rows	20201217_04bb31a9-1682-4941-a7cb-a6526d226776.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YF7V70N02B	ULIPRISTAL ACETATE	126784-99-4	ULIPRISTAL ACETATE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1005928	Ella 30 MG Oral Tablet	PSN	04bb31a9-1682-4941-a7cb-a6526d226776	5
1005924	ulipristal acetate 30 MG Oral Tablet	PSN	04bb31a9-1682-4941-a7cb-a6526d226776	5
1005928	ulipristal acetate 30 MG Oral Tablet [Ella]	SBD	04bb31a9-1682-4941-a7cb-a6526d226776	5
1005924	ulipristal acetate 30 MG Oral Tablet	SCD	04bb31a9-1682-4941-a7cb-a6526d226776	5
1005928	Ella 30 MG Oral Tablet	SY	04bb31a9-1682-4941-a7cb-a6526d226776	5

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53002-1630-1	53002163001	1 TABLET in 1 DOSE PACK (53002-1630-1)	1 tablet	2018-10-02	0000-00-00	No	No	Current