FDA.reportPublic FDA data

Rosuvastatin

Product NDC
55700-574
11-digit product format
557000574
Labeler code
55700
Product ID
55700-574_50c77cf2-2262-452c-af14-1de0fb60556e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Lake Erie Medical DBA Quality Care Products LLC
Application
ANDA207616
Marketing category
ANDA
Marketing start
2018-01-05
Marketing end
0000-00-00
Substance
ROSUVASTATIN CALCIUM
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC],Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-574-302022-01-13C16284748780-1ba0f9c33-1c85-a910-e053-dadaa90a0b85616fd0c5-39c8-4276-9bcd-b045a08d08de
55700-574-302021-01-29C16284748780-1ba0f9c33-1c85-a910-e053-dadaa90a0b85616fd0c5-39c8-4276-9bcd-b045a08d08de

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-574-30EA - Each55700-574ee94bbcd-0602-4073-8268-4981c87f9e3912018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-574ROSUVASTATIN TABLET, FILM COATED [QUALITY CARE PRODUCTS, LLC]9Legacy NDC20250101_616fd0c5-39c8-4276-9bcd-b045a08d08de.zip