Raloxifene Hydrochloride

Product NDC: 50090-5458
11-digit product format: 500905458
Labeler code: 50090
Product ID: 50090-5458_6ebda497-aa09-4efb-8136-223422b0f8a2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Raloxifene
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA090842
Marketing category: ANDA
Marketing start: 2016-06-29
Marketing end: 0000-00-00
Substance: RALOXIFENE HYDROCHLORIDE
Active strength: 60 mg/1
Pharmacologic classes: Estrogen Agonist/Antagonist [EPC],Selective Estrogen Receptor Modulators [MoA]
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
7ad62b49-6132-2a8c-4edd-73f39b2bf45c	Product name	6	20210312
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-5458-1	2023-01-30	C162847	48780-1	f386c64a-1867-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use raloxifene hydrochloride tablets, USP safely and effectively. See full prescribing information for raloxifene hydrochloride tablets, USP. Raloxifene Hydrochloride Tablets, USP for Oral Use Initial U.S. Approval: 1997

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-5458-1	Raloxifene Hydrochloride	90 in 1 BOTTLE	TABLET	90		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-5458	RALOXIFENE HYDROCHLORIDE (RALOXIFENE) TABLET [A-S MEDICATION SOLUTIONS]	1	Legacy NDC, 1 package rows	20210303_35b5e3e5-0dfe-4abe-a928-d91dedd450e1.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4F86W47BR6	RALOXIFENE HYDROCHLORIDE	82640-04-8	RALOXIFENE HYDROCHLORIDE
YX9162EO3I	RALOXIFENE	84449-90-1	Raloxifene

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1490065	raloxifene HCl 60 MG Oral Tablet	PSN	35b5e3e5-0dfe-4abe-a928-d91dedd450e1	1
1490065	raloxifene hydrochloride 60 MG Oral Tablet	SCD	35b5e3e5-0dfe-4abe-a928-d91dedd450e1	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5458-1	50090545801	90 TABLET in 1 BOTTLE (50090-5458-1)	90 tablet	2021-01-29	0000-00-00	No	No	Current