FDA.reportPublic FDA data

ROSUVASTATIN

Substance profile for UNII 413KH5ZJ73, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for ROSUVASTATIN
Structure render from PubChem CID 446157

Substance Identity#

UNII
413KH5ZJ73
Preferred term
ROSUVASTATIN
Registry number
287714-41-4
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C22H28FN3O6S
Chemical structure for ROSUVASTATIN
Structure render from PubChem CID 446157

Chemical And Database Identifiers#

InChIKey
BPRHUIZQVSMCRT-VEUZHWNKSA-N
SMILES
CC(C)C1=C(\C=C\[C@@H](O)C[C@@H](O)CC(O)=O)C(=NC(=N1)N(C)S(C)(=O)=O)C2=CC=C(F)C=C2
RxCUI
301542
PubChem
446157
NCIt
C66523
INN ID
8021

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound446157pubchem.ncbi.nlm.nih.gov/compound/446157
PubChem InChIKey SearchBPRHUIZQVSMCRT-VEUZHWNKSA-Npubchem.ncbi.nlm.nih.gov/#query=BPRHUIZQVSMCRT-VEUZHWNKSA-N
RxNorm301542mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=301542
NCI ThesaurusC66523ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C66523
FDA Substance Registration System413KH5ZJ73precision.fda.gov/uniisearch/srs/unii/413KH5ZJ73

DailyMed Socrata Ingredients#

DailyMed label, SPL version table
DailyMed labelSPL version
These highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR. CRESTOR (rosuvastatin calcium) tablets Initial U.S. Approval: 20032
These highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR. CRESTOR (rosuvastatin calcium) tablets Initial U.S. Approval: 20033
These highlights do not include all the information needed to use CRESTOR safely and effectively. See full prescribing information for CRESTOR. CRESTOR (rosuvastatin calcium) tablets Initial U.S. Approval: 20031
CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [LAKE ERIE MEDICAL & SURGUCAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3591
CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [BRYANT RANCH PREPACK]1000
CRESTOR (ROSUVASTATIN CALCIUM) TABLET, COATED [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]454
CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [ASTRAZENECA PHARMACEUTICALS LP]30
CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18
CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18
CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [CARDINAL HEALTH]12
CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [CARDINAL HEALTH]4
CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [CARDINAL HEALTH]4
CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [BRYANT RANCH PREPACK]2
CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [CARDINAL HEALTH]2
CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [CARILION MATERIALS MANAGEMENT]2
CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [REMEDYREPACK INC. ]2
CRESTOR (ROSUVASTATIN CALCIUM) TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1