FDA.reportPublic FDA data

ROSUVASTATIN CALCIUM

Product NDC
61919-712
11-digit product format
619190712
Labeler code
61919
Product ID
61919-712_874bd64a-5af9-221e-e053-2995a90a6f79
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ROSUVASTATIN CALCIUM
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA206434
Marketing category
ANDA
Marketing start
2018-11-13
Marketing end
0000-00-00
Substance
ROSUVASTATIN CALCIUM
Active strength
40 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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-712-902021-01-29C16284748780-1ba0f9c33-1c9d-a910-e053-dadaa90a0b85ROSUVASTATIN CALCIUM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-712-90ROSUVASTATIN CALCIUM90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-712-90EA - Each61919-712a4c993ca-47a8-4586-91e7-2c48a8c012b712019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-712ROSUVASTATIN CALCIUM TABLET, FILM COATED ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUN) TABLET, FILM COATED [DIRECT RX]3Legacy NDC, 1 package rows20190425_7a8db339-b98c-6fab-e053-2a91aa0a1247.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859751rosuvastatin calcium 20 MG Oral TabletPSN7a8db339-b98c-6fab-e053-2a91aa0a12473
859419rosuvastatin calcium 40 MG Oral TabletPSN7a8db339-b98c-6fab-e053-2a91aa0a12473
859424rosuvastatin calcium 5 MG Oral TabletPSN7a8db339-b98c-6fab-e053-2a91aa0a12473
859751rosuvastatin calcium 20 MG Oral TabletSCD7a8db339-b98c-6fab-e053-2a91aa0a12473
859419rosuvastatin calcium 40 MG Oral TabletSCD7a8db339-b98c-6fab-e053-2a91aa0a12473
859424rosuvastatin calcium 5 MG Oral TabletSCD7a8db339-b98c-6fab-e053-2a91aa0a12473

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-712-906191907129090 in 1 BOTTLEHistorical