FDA.reportPublic FDA data

Rosuvastatin calcium

Product NDC
68462-261
11-digit product format
684620261
Labeler code
68462
Product ID
68462-261_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
5 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 CALCIUM5 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
68462-261-01Rosuvastatin calcium100 in 1 BOTTLETABLET, FILM COATED10013
68462-261-10Rosuvastatin calcium1000 in 1 BOTTLETABLET, FILM COATED100013
68462-261-11Rosuvastatin calcium10 in 1 CARTONTABLET, FILM COATED1013
68462-261-11Rosuvastatin calcium10 in 1 BLISTER PACKTABLET, FILM COATED1013
68462-261-30Rosuvastatin calcium30 in 1 BOTTLETABLET, FILM COATED3013
68462-261-50Rosuvastatin calcium50 in 1 BOTTLETABLET, FILM COATED5013
68462-261-90Rosuvastatin calcium90 in 1 BOTTLETABLET, FILM COATED9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68462-261ROSUVASTATIN 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
859424rosuvastatin calcium 5 MG Oral TabletPSNf07922e5-a963-4ecf-86db-c1ae12f852248
859424rosuvastatin calcium 5 MG Oral TabletSCDf07922e5-a963-4ecf-86db-c1ae12f852248
859424rosuvastatin calcium 5 MG Oral TabletPSNe432e043-c019-4d58-94ca-7c1d85f5cd404
859424rosuvastatin calcium 5 MG Oral TabletSCDe432e043-c019-4d58-94ca-7c1d85f5cd404
859424rosuvastatin calcium 5 MG Oral TabletPSN1d86f10c-1e47-cefc-e063-6394a90a9f2e3
859424rosuvastatin calcium 5 MG Oral TabletSCD1d86f10c-1e47-cefc-e063-6394a90a9f2e3
859424rosuvastatin calcium 5 MG Oral TabletPSN45033c5f-4246-491a-8707-10f840ff2b6c1
859424rosuvastatin calcium 5 MG Oral TabletSCD45033c5f-4246-491a-8707-10f840ff2b6c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68462-261-0168462026101100 TABLET, FILM COATED in 1 BOTTLE (68462-261-01) 2016-07-190000-00-00NoNoCurrent
68462-261-10684620261101000 TABLET, FILM COATED in 1 BOTTLE (68462-261-10) 2016-07-190000-00-00NoNoCurrent
68462-261-116846202611110 BLISTER PACK in 1 CARTON (68462-261-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2016-07-190000-00-00NoNoCurrent
68462-261-306846202613030 TABLET, FILM COATED in 1 BOTTLE (68462-261-30) 2016-07-190000-00-00NoNoCurrent
68462-261-506846202615050 TABLET, FILM COATED in 1 BOTTLE (68462-261-50) 2016-07-190000-00-00NoNoCurrent
68462-261-906846202619090 TABLET, FILM COATED in 1 BOTTLE (68462-261-90) 2016-07-190000-00-00NoNoCurrent