FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
16714-988
11-digit product format
167140988
Labeler code
16714
Product ID
16714-988_af3a6349-8b25-462d-9fbf-3e95c32734df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar RxLLC
Application
ANDA079172
Marketing category
ANDA
Marketing start
2019-06-27
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
16714-988-01Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED908

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-988-01EA - Each16714-988b640540f-f259-4dcd-a083-3891e47e523212019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-988ROSUVASTATIN CALCIUM TABLET, FILM COATED [NORTHSTAR RXLLC]7Current NDC, Legacy NDC, 1 package rows20231110_17d71c80-fade-4735-acec-60738d26dd01.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSN17d71c80-fade-4735-acec-60738d26dd018
859751rosuvastatin calcium 20 MG Oral TabletPSN17d71c80-fade-4735-acec-60738d26dd018
859419rosuvastatin calcium 40 MG Oral TabletPSN17d71c80-fade-4735-acec-60738d26dd018
859424rosuvastatin calcium 5 MG Oral TabletPSN17d71c80-fade-4735-acec-60738d26dd018
859747rosuvastatin calcium 10 MG Oral TabletSCD17d71c80-fade-4735-acec-60738d26dd018
859751rosuvastatin calcium 20 MG Oral TabletSCD17d71c80-fade-4735-acec-60738d26dd018
859419rosuvastatin calcium 40 MG Oral TabletSCD17d71c80-fade-4735-acec-60738d26dd018
859424rosuvastatin calcium 5 MG Oral TabletSCD17d71c80-fade-4735-acec-60738d26dd018
859424rosuvastatin calcium 5 MG Oral TabletPSN3493b809-74b0-71b0-e063-6294a90a9a992
859424rosuvastatin calcium 5 MG Oral TabletSCD3493b809-74b0-71b0-e063-6294a90a9a992
859424rosuvastatin calcium 5 MG Oral TabletPSN76568df9-1a56-4e23-ac84-28f3b72cc2421
859424rosuvastatin calcium 5 MG Oral TabletPSN82308a25-97e8-44ba-a6c4-d6e03d08cd6a1
859424rosuvastatin calcium 5 MG Oral TabletSCD76568df9-1a56-4e23-ac84-28f3b72cc2421
859424rosuvastatin calcium 5 MG Oral TabletSCD82308a25-97e8-44ba-a6c4-d6e03d08cd6a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-988-011671409880190 TABLET, FILM COATED in 1 BOTTLE (16714-988-01) 2019-06-270000-00-00NoNoCurrent