FDA.reportPublic FDA data

Rosuvastatin

Product NDC
16729-285
11-digit product format
167290285
Labeler code
16729
Product ID
16729-285_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
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
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
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
16729-285-10Rosuvastatin30 in 1 BOTTLETABLET, FILM COATED3011
16729-285-15Rosuvastatin90 in 1 BOTTLETABLET, FILM COATED9011
16729-285-17Rosuvastatin1000 in 1 BOTTLETABLET, FILM COATED100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-285-15EA - Each16729-285662a7bce-8ab5-458d-9113-86b3d4a5517212016-11-08
16729-285-17EA - Each16729-2855a42b3cf-42ea-49c2-ac54-e76208f0547e12016-11-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-285ROSUVASTATIN 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 TabletPSNaa7443b0-9f75-47fc-a5ce-c7245444419c103
859747rosuvastatin calcium 10 MG Oral TabletSCDaa7443b0-9f75-47fc-a5ce-c7245444419c103
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
859747rosuvastatin calcium 10 MG Oral TabletPSN662c6f1a-ca1e-40ea-952d-122b680fdb896
859747rosuvastatin calcium 10 MG Oral TabletSCD662c6f1a-ca1e-40ea-952d-122b680fdb896
859747rosuvastatin calcium 10 MG Oral TabletPSN5a874865-3cbe-4589-9787-046feb9a2c465
859747rosuvastatin calcium 10 MG Oral TabletSCD5a874865-3cbe-4589-9787-046feb9a2c465
859747rosuvastatin calcium 10 MG Oral TabletPSNa5ee9510-e691-49ec-a5cd-49e70371ee4d1
859747rosuvastatin calcium 10 MG Oral TabletPSNe673ddcb-884b-e62d-e053-2995a90acc441
859747rosuvastatin calcium 10 MG Oral TabletSCDa5ee9510-e691-49ec-a5cd-49e70371ee4d1
859747rosuvastatin calcium 10 MG Oral TabletSCDe673ddcb-884b-e62d-e053-2995a90acc441

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16729-285-101672902851030 TABLET, FILM COATED in 1 BOTTLE (16729-285-10) 2020-01-010000-00-00NoNoCurrent
16729-285-151672902851590 TABLET, FILM COATED in 1 BOTTLE (16729-285-15) 2016-10-310000-00-00NoNoCurrent
16729-285-17167290285171000 TABLET, FILM COATED in 1 BOTTLE (16729-285-17) 2016-10-310000-00-00NoNoCurrent