FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
42677-301
11-digit product format
426770301
Labeler code
42677
Product ID
42677-301_47b31d1c-f321-11d2-e063-6294a90af883
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Shandong New Time Pharmaceutical Co., Ltd.
Application
ANDA207375
Marketing category
ANDA
Marketing start
2022-01-22
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rosuvastatin Calcium
Listing expiration
2027-12-31

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
c8f25656-847a-4de8-96a7-06bf98d83c2bProduct name120210916
b6a872b4-e31a-fff0-6f62-fd0253265e2fProduct name920190618
5a2818e5-ef92-49b1-bc6c-9fe2427d21d5Product name120190429

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42677-301-01Rosuvastatin Calcium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED9011
42677-301-02Rosuvastatin Calcium500 in 1 BOTTLE, PLASTICTABLET, FILM COATED50011
42677-301-01Rosuvastatin Calcium90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902
42677-301-02Rosuvastatin Calcium500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42677-301ROSUVASTATIN CALCIUM TABLET, FILM COATED [SHANDONG NEW TIME PHARMACEUTICAL CO., LTD.]10Current NDC, Legacy NDC, 2 package rows20241127_ce767751-696f-4750-8438-a276ae999137.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859747rosuvastatin calcium 10 MG Oral TabletPSNce767751-696f-4750-8438-a276ae99913711
859424rosuvastatin calcium 5 MG Oral TabletPSNce767751-696f-4750-8438-a276ae99913711
859747rosuvastatin calcium 10 MG Oral TabletSCDce767751-696f-4750-8438-a276ae99913711
859424rosuvastatin calcium 5 MG Oral TabletSCDce767751-696f-4750-8438-a276ae99913711
859747rosuvastatin calcium 10 MG Oral TabletPSNae865404-ecf4-41a8-b40b-62f887c220f22
859751rosuvastatin calcium 20 MG Oral TabletPSNae865404-ecf4-41a8-b40b-62f887c220f22
859419rosuvastatin calcium 40 MG Oral TabletPSNae865404-ecf4-41a8-b40b-62f887c220f22
859424rosuvastatin calcium 5 MG Oral TabletPSNae865404-ecf4-41a8-b40b-62f887c220f22
859747rosuvastatin calcium 10 MG Oral TabletSCDae865404-ecf4-41a8-b40b-62f887c220f22
859751rosuvastatin calcium 20 MG Oral TabletSCDae865404-ecf4-41a8-b40b-62f887c220f22
859419rosuvastatin calcium 40 MG Oral TabletSCDae865404-ecf4-41a8-b40b-62f887c220f22
859424rosuvastatin calcium 5 MG Oral TabletSCDae865404-ecf4-41a8-b40b-62f887c220f22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42677-301-014267703010190 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-301-01) 2022-01-220000-00-00NoNoCurrent
42677-301-0242677030102500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (42677-301-02) 2022-01-220000-00-00NoNoCurrent