Rosuvastatin

Product NDC
55700-978
11-digit product format
557000978
Labeler code
55700
Product ID
55700-978_14f96662-8b61-4d6e-9b66-b42601414be4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA206434
Marketing category
ANDA
Marketing start
2022-07-20
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
2023-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55700-978-302025-01-13C16284748780-11030e365-5c8b-111a-e063-dadaa90a10e2dc90eafe-d596-4b74-83ce-5197ad2478ea
55700-978-302024-01-30C16284748780-11030e365-5c8b-111a-e063-dadaa90a10e2dc90eafe-d596-4b74-83ce-5197ad2478ea

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-978-30EA - Each55700-9789dc29575-d15b-40d7-a5c7-98102bf05aef12022-09-12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-978-305570009783030 TABLET, FILM COATED in 1 BOTTLE (55700-978-30) 2022-07-200000-00-00NoNoCurrent