Raloxifene Hydrochloride

Product NDC: 68071-2412
11-digit product format: 680712412
Labeler code: 68071
Product ID: 68071-2412_c2dfd166-64d1-b784-e053-2a95a90ae882
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Raloxifene Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA078193
Marketing category: ANDA
Marketing start: 2014-03-28
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
7ad62b49-6132-2a8c-4edd-73f39b2bf45c	Product name	6	20210312

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2412-3	2023-01-30	C162847	48780-1	f386c649-bfee-0266-e053-dadaa90a7c1a	These highlights do not include all the information needed to use RALOXIFENE HYDROCHLORIDE TABLETS safely and effectively. See full prescribing information for RALOXIFENE HYDROCHLORIDE TABLETS. RALOXIFENE HYDROCHLORIDE tablets, for oral use Initial U.S. Approval: 1997

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2412-3	Raloxifene Hydrochloride	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2412	RALOXIFENE HYDROCHLORIDE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20210525_c2dfd193-dd49-61e3-e053-2995a90a8efb.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4F86W47BR6	RALOXIFENE HYDROCHLORIDE	82640-04-8	RALOXIFENE HYDROCHLORIDE

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1490065	raloxifene HCl 60 MG Oral Tablet	PSN	c2dfd193-dd49-61e3-e053-2995a90a8efb	1
1490065	raloxifene hydrochloride 60 MG Oral Tablet	SCD	c2dfd193-dd49-61e3-e053-2995a90a8efb	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2412-3	68071241203	30 TABLET, FILM COATED in 1 BOTTLE (68071-2412-3)	2021-05-21	0000-00-00	No	No	Current