Rosuvastatin

Product NDC: 68071-2848
11-digit product format: 680712848
Labeler code: 68071
Product ID: 68071-2848_eab1d8a7-e4e3-65bf-e053-2995a90a1b40
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rosuvastatin
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA207616
Marketing category: ANDA
Marketing start: 2016-10-29
Marketing end: 0000-00-00
Substance: ROSUVASTATIN CALCIUM
Active strength: 20 mg/1
Pharmacologic classes: HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
c8f25656-847a-4de8-96a7-06bf98d83c2b	Product name	1	20210916
b6a872b4-e31a-fff0-6f62-fd0253265e2f	Product name	9	20190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5	Product name	1	20190429

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-2848-9	2025-01-30	C162847	48780-1	2cef2736-a16a-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2848-9	Rosuvastatin	90 in 1 BOTTLE	TABLET, FILM COATED	90		1

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2848	ROSUVASTATIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20221011_eab1d8a7-e4e2-65bf-e053-2995a90a1b40.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
83MVU38M7Q	ROSUVASTATIN CALCIUM	147098-20-2	ROSUVASTATIN CALCIUM
413KH5ZJ73	ROSUVASTATIN	287714-41-4	Rosuvastatin

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
859751	rosuvastatin calcium 20 MG Oral Tablet	PSN	eab1d8a7-e4e2-65bf-e053-2995a90a1b40	1
859751	rosuvastatin calcium 20 MG Oral Tablet	SCD	eab1d8a7-e4e2-65bf-e053-2995a90a1b40	1

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2848-9	68071284809	90 TABLET, FILM COATED in 1 BOTTLE (68071-2848-9)	2022-10-10	0000-00-00	No	No	Current