FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
13668-720
11-digit product format
136680720
Labeler code
13668
Product ID
13668-720_4580eab3-3229-1af6-e063-6394a90af35c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET
Route
ORAL
Labeler
TORRENT PHARMACEUTICALS LIMITED
Application
ANDA207626
Marketing category
ANDA
Marketing start
2023-08-01
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
13668-720-05Rosuvastatin Calcium500 in 1 BOTTLETABLET5008
13668-720-10Rosuvastatin Calcium1000 in 1 BOTTLETABLET10008
13668-720-90Rosuvastatin Calcium90 in 1 BOTTLETABLET908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-720-05EA - Each13668-720dee56bdf-593d-4480-a87e-4f6b364f71fe12024-02-14
13668-720-90EA - Each13668-720b832b633-d864-4cf0-86f4-7026bf5e209412024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-720ROSUVASTATIN CALCIUM (ROSUVASTATIN CALCIUM) TABLET [TORRENT PHARMACEUTICALS LIMITED]7Current NDC, 3 package rows20250313_6985e729-d963-4f32-89a1-727472b86daa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN6985e729-d963-4f32-89a1-727472b86daa8
859751rosuvastatin calcium 20 MG Oral TabletPSN6985e729-d963-4f32-89a1-727472b86daa8
859419rosuvastatin calcium 40 MG Oral TabletPSN6985e729-d963-4f32-89a1-727472b86daa8
859424rosuvastatin calcium 5 MG Oral TabletPSN6985e729-d963-4f32-89a1-727472b86daa8
859747rosuvastatin calcium 10 MG Oral TabletSCD6985e729-d963-4f32-89a1-727472b86daa8
859751rosuvastatin calcium 20 MG Oral TabletSCD6985e729-d963-4f32-89a1-727472b86daa8
859419rosuvastatin calcium 40 MG Oral TabletSCD6985e729-d963-4f32-89a1-727472b86daa8
859424rosuvastatin calcium 5 MG Oral TabletSCD6985e729-d963-4f32-89a1-727472b86daa8
859424rosuvastatin calcium 5 MG Oral TabletPSN1346ab60-808b-442b-8217-a59bb9986f032
859424rosuvastatin calcium 5 MG Oral TabletSCD1346ab60-808b-442b-8217-a59bb9986f032
859424rosuvastatin calcium 5 MG Oral TabletPSN20101145-4c4f-8f0a-e063-6394a90ae27d1
859424rosuvastatin calcium 5 MG Oral TabletSCD20101145-4c4f-8f0a-e063-6394a90ae27d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
13668-720-0513668072005500 TABLET in 1 BOTTLE (13668-720-05) 500 tablet2023-08-01NoNoCurrent
13668-720-10136680720101000 TABLET in 1 BOTTLE (13668-720-10) 1000 tablet2024-12-20NoNoCurrent
13668-720-901366807209090 TABLET in 1 BOTTLE (13668-720-90) 90 tablet2023-08-01NoNoCurrent