FDA.reportPublic FDA data

Rosuvastatin

Product NDC
16729-287
11-digit product format
167290287
Labeler code
16729
Product ID
16729-287_4390ed19-e509-95ab-e063-6294a90a2b08
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA206434
Marketing category
ANDA
Marketing start
2016-10-31
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ROSUVASTATIN CALCIUM40 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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-287-10Rosuvastatin30 in 1 BOTTLETABLET, FILM COATED3011
16729-287-15Rosuvastatin90 in 1 BOTTLETABLET, FILM COATED9011
16729-287-17Rosuvastatin1000 in 1 BOTTLETABLET, FILM COATED100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-287-10EA - Each16729-28789c2f7ff-675a-448a-84d0-9d11cee4a16712016-11-08
16729-287-15EA - Each16729-2876bd3e744-72da-4314-9481-5ad4bc5a291912016-11-08
16729-287-17EA - Each16729-2877a17f977-0dde-4f22-a21e-3ead1326143c12016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-287ROSUVASTATIN TABLET, FILM COATED [ACCORD HEALTHCARE INC.]10Current NDC, Legacy NDC, 3 package rows20241003_3ffe0294-3997-2755-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN3ffe0294-3997-2755-e054-00144ff8d46c11
859751rosuvastatin calcium 20 MG Oral TabletPSN3ffe0294-3997-2755-e054-00144ff8d46c11
859419rosuvastatin calcium 40 MG Oral TabletPSN3ffe0294-3997-2755-e054-00144ff8d46c11
859424rosuvastatin calcium 5 MG Oral TabletPSN3ffe0294-3997-2755-e054-00144ff8d46c11
859747rosuvastatin calcium 10 MG Oral TabletSCD3ffe0294-3997-2755-e054-00144ff8d46c11
859751rosuvastatin calcium 20 MG Oral TabletSCD3ffe0294-3997-2755-e054-00144ff8d46c11
859419rosuvastatin calcium 40 MG Oral TabletSCD3ffe0294-3997-2755-e054-00144ff8d46c11
859424rosuvastatin calcium 5 MG Oral TabletSCD3ffe0294-3997-2755-e054-00144ff8d46c11
859751rosuvastatin calcium 20 MG Oral TabletPSN7a8db339-b98c-6fab-e053-2a91aa0a12473
859419rosuvastatin calcium 40 MG Oral TabletPSN73bcb15c-5529-4589-b242-ed23e1e0f08b3
859419rosuvastatin calcium 40 MG Oral TabletPSNa1b4d50b-eda3-437c-9c80-4d854361ddc23
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 TabletSCD73bcb15c-5529-4589-b242-ed23e1e0f08b3
859419rosuvastatin calcium 40 MG Oral TabletSCD7a8db339-b98c-6fab-e053-2a91aa0a12473
859419rosuvastatin calcium 40 MG Oral TabletSCDa1b4d50b-eda3-437c-9c80-4d854361ddc23
859424rosuvastatin calcium 5 MG Oral TabletSCD7a8db339-b98c-6fab-e053-2a91aa0a12473
859419rosuvastatin calcium 40 MG Oral TabletPSN69dfa637-2a81-4c7e-8fef-d4b4ab4c3f251
859419rosuvastatin calcium 40 MG Oral TabletPSN7defe9df-8eb9-15d3-e053-2a91aa0a6be61
859419rosuvastatin calcium 40 MG Oral TabletSCD7defe9df-8eb9-15d3-e053-2a91aa0a6be61
859419rosuvastatin calcium 40 MG Oral TabletSCD69dfa637-2a81-4c7e-8fef-d4b4ab4c3f251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-287-101672902871030 TABLET, FILM COATED in 1 BOTTLE (16729-287-10) 2016-10-310000-00-00NoNoCurrent
16729-287-151672902871590 TABLET, FILM COATED in 1 BOTTLE (16729-287-15) 2016-10-310000-00-00NoNoCurrent
16729-287-17167290287171000 TABLET, FILM COATED in 1 BOTTLE (16729-287-17) 2016-10-310000-00-00NoNoCurrent