FDA.reportPublic FDA data

Rosuvastatin calcium

Product NDC
68462-262
11-digit product format
684620262
Labeler code
68462
Product ID
68462-262_958b8936-9395-42e0-8c3b-3247a20621c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Glenmark Pharmaceutials Inc., USA
Application
ANDA079172
Marketing category
ANDA
Marketing start
2016-07-19
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rosuvastatin calcium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii83MVU38M7Q
Rxcui859419, 859424, 859747, 859751

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
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
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68462-262-01Rosuvastatin calcium100 in 1 BOTTLETABLET, FILM COATED10013
68462-262-10Rosuvastatin calcium1000 in 1 BOTTLETABLET, FILM COATED100013
68462-262-11Rosuvastatin calcium10 in 1 CARTONTABLET, FILM COATED1013
68462-262-11Rosuvastatin calcium10 in 1 BLISTER PACKTABLET, FILM COATED1013
68462-262-30Rosuvastatin calcium30 in 1 BOTTLETABLET, FILM COATED3013
68462-262-50Rosuvastatin calcium50 in 1 BOTTLETABLET, FILM COATED5013
68462-262-90Rosuvastatin calcium90 in 1 BOTTLETABLET, FILM COATED9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68462-262-10EA - Each68462-262920336b9-d693-47e7-aa85-e715b396d4fc12021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-262ROSUVASTATIN CALCIUM TABLET, FILM COATED [GLENMARK PHARMACEUTIALS INC., USA]12Current NDC, Legacy NDC, 7 package rows20240928_392657a9-955c-42c2-814c-1890ece45afa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN392657a9-955c-42c2-814c-1890ece45afa13
859751rosuvastatin calcium 20 MG Oral TabletPSN392657a9-955c-42c2-814c-1890ece45afa13
859419rosuvastatin calcium 40 MG Oral TabletPSN392657a9-955c-42c2-814c-1890ece45afa13
859424rosuvastatin calcium 5 MG Oral TabletPSN392657a9-955c-42c2-814c-1890ece45afa13
859747rosuvastatin calcium 10 MG Oral TabletSCD392657a9-955c-42c2-814c-1890ece45afa13
859751rosuvastatin calcium 20 MG Oral TabletSCD392657a9-955c-42c2-814c-1890ece45afa13
859419rosuvastatin calcium 40 MG Oral TabletSCD392657a9-955c-42c2-814c-1890ece45afa13
859424rosuvastatin calcium 5 MG Oral TabletSCD392657a9-955c-42c2-814c-1890ece45afa13
859747rosuvastatin calcium 10 MG Oral TabletPSN2aa6d21f-426a-42b0-aa96-4cc47f97f7ab7
859747rosuvastatin calcium 10 MG Oral TabletSCD2aa6d21f-426a-42b0-aa96-4cc47f97f7ab7
859747rosuvastatin calcium 10 MG Oral TabletPSN94245f53-2892-4209-8c94-c32c87d5b1066
859747rosuvastatin calcium 10 MG Oral TabletSCD94245f53-2892-4209-8c94-c32c87d5b1066
859747rosuvastatin calcium 10 MG Oral TabletPSNf80b8d59-2c22-8fff-e053-6294a90a2f9e4
859747rosuvastatin calcium 10 MG Oral TabletSCDf80b8d59-2c22-8fff-e053-6294a90a2f9e4
859747rosuvastatin calcium 10 MG Oral TabletPSN4148e0b3-0340-9f3a-e063-6394a90afc962
859751rosuvastatin calcium 20 MG Oral TabletPSN4148e0b3-0340-9f3a-e063-6394a90afc962
859747rosuvastatin calcium 10 MG Oral TabletSCD4148e0b3-0340-9f3a-e063-6394a90afc962
859751rosuvastatin calcium 20 MG Oral TabletSCD4148e0b3-0340-9f3a-e063-6394a90afc962
859747rosuvastatin calcium 10 MG Oral TabletPSN8bd56c80-2f98-4b6e-809e-d0e981c3dcb31
859747rosuvastatin calcium 10 MG Oral TabletPSN413d877a-87b1-4b8a-ae99-283688e804b51
859747rosuvastatin calcium 10 MG Oral TabletSCD8bd56c80-2f98-4b6e-809e-d0e981c3dcb31
859747rosuvastatin calcium 10 MG Oral TabletSCD413d877a-87b1-4b8a-ae99-283688e804b51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-262-0168462026201100 TABLET, FILM COATED in 1 BOTTLE (68462-262-01) 2016-07-190000-00-00NoNoCurrent
68462-262-10684620262101000 TABLET, FILM COATED in 1 BOTTLE (68462-262-10) 2016-07-190000-00-00NoNoCurrent
68462-262-116846202621110 BLISTER PACK in 1 CARTON (68462-262-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2016-07-190000-00-00NoNoCurrent
68462-262-306846202623030 TABLET, FILM COATED in 1 BOTTLE (68462-262-30) 2016-07-190000-00-00NoNoCurrent
68462-262-506846202625050 TABLET, FILM COATED in 1 BOTTLE (68462-262-50) 2016-07-190000-00-00NoNoCurrent
68462-262-906846202629090 TABLET, FILM COATED in 1 BOTTLE (68462-262-90) 2016-07-190000-00-00NoNoCurrent