Rosuvastatin calcium

Product NDC
55700-998
11-digit product format
557000998
Labeler code
55700
Product ID
55700-998_d4a9987c-4ce5-497e-8096-8c75ef7d097f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA207752
Marketing category
ANDA
Marketing start
2023-01-24
Marketing end
2026-06-30
Substance
ROSUVASTATIN CALCIUM
Active strength
10 mg/1
Pharmacologic classes
HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
83MVU38M7QROSUVASTATIN CALCIUM147098-20-2ROSUVASTATIN CALCIUM

Packages

Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55700-998-305570009983030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (55700-998-30) 2023-01-242026-06-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Rosuvastatin calciumQuality Care Products, LLC2024-12-19HUMAN PRESCRIPTION DRUG LABEL4