FDA.reportPublic FDA data

Rosuvastatin

Product NDC
16729-284
11-digit product format
167290284
Labeler code
16729
Product ID
16729-284_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
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
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16729-284-10Rosuvastatin30 in 1 BOTTLETABLET, FILM COATED3011
16729-284-15Rosuvastatin90 in 1 BOTTLETABLET, FILM COATED9011
16729-284-17Rosuvastatin1000 in 1 BOTTLETABLET, FILM COATED100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-284-15EA - Each16729-2842b1bc238-7cd8-4991-b7f6-86578abad1c112016-11-08
16729-284-17EA - Each16729-2841707d3ea-864e-43fb-96ee-309312d7933312016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-284ROSUVASTATIN 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
859424rosuvastatin calcium 5 MG Oral TabletPSN0ad5b7de-e97d-4989-91e4-edae73543896103
859424rosuvastatin calcium 5 MG Oral TabletSCD0ad5b7de-e97d-4989-91e4-edae73543896103
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
859424rosuvastatin calcium 5 MG Oral TabletPSNeaf91ddd-0d4f-4c77-9dba-a2a3abb86ea42
859424rosuvastatin calcium 5 MG Oral TabletSCDeaf91ddd-0d4f-4c77-9dba-a2a3abb86ea42
859424rosuvastatin calcium 5 MG Oral TabletPSNf3240c45-c689-46b1-bd37-eef49b59d1981
859424rosuvastatin calcium 5 MG Oral TabletSCDf3240c45-c689-46b1-bd37-eef49b59d1981

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-284-101672902841030 TABLET, FILM COATED in 1 BOTTLE (16729-284-10) 2020-01-010000-00-00NoNoCurrent
16729-284-151672902841590 TABLET, FILM COATED in 1 BOTTLE (16729-284-15) 2016-10-310000-00-00NoNoCurrent
16729-284-17167290284171000 TABLET, FILM COATED in 1 BOTTLE (16729-284-17) 2016-10-310000-00-00NoNoCurrent