FDA.reportPublic FDA data

Rosuvastatin Calcium

Product NDC
27808-158
11-digit product format
278080158
Labeler code
27808
Product ID
27808-158_6c4547c4-9429-42e5-998f-e97f6a74f150
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Rosuvastatin Calcium
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cranbury Pharmaceuticals, LLC
Application
ANDA207408
Marketing category
ANDA
Marketing start
2018-01-08
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 Calcium
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
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
27808-158-01Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED3011
27808-158-02Rosuvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED100011
27808-158-03Rosuvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED50011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27808-158-01EA - Each27808-158ab418969-2744-4e5d-be2e-ba906c2d495512018-03-08
27808-158-03EA - Each27808-15880fe9c2d-0e57-49c8-9e30-9c6f05e30f1412019-11-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27808-158ROSUVASTATIN CALCIUM TABLET, FILM COATED [CRANBURY PHARMACEUTICALS, LLC]11Current NDC, Legacy NDC, 3 package rows20250330_606d16fb-82e4-420d-9456-09997562b528.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
859419rosuvastatin calcium 40 MG Oral TabletPSNc277c6fd-f8dd-41d8-8686-38c25d05d192103
859419rosuvastatin calcium 40 MG Oral TabletSCDc277c6fd-f8dd-41d8-8686-38c25d05d192103
859747rosuvastatin calcium 10 MG Oral TabletPSN606d16fb-82e4-420d-9456-09997562b52811
859751rosuvastatin calcium 20 MG Oral TabletPSN606d16fb-82e4-420d-9456-09997562b52811
859419rosuvastatin calcium 40 MG Oral TabletPSN606d16fb-82e4-420d-9456-09997562b52811
859424rosuvastatin calcium 5 MG Oral TabletPSN606d16fb-82e4-420d-9456-09997562b52811
859747rosuvastatin calcium 10 MG Oral TabletSCD606d16fb-82e4-420d-9456-09997562b52811
859751rosuvastatin calcium 20 MG Oral TabletSCD606d16fb-82e4-420d-9456-09997562b52811
859419rosuvastatin calcium 40 MG Oral TabletSCD606d16fb-82e4-420d-9456-09997562b52811
859424rosuvastatin calcium 5 MG Oral TabletSCD606d16fb-82e4-420d-9456-09997562b52811
859747rosuvastatin calcium 10 MG Oral TabletPSN7c3af5aa-2223-463a-e053-2a91aa0a16f910
859751rosuvastatin calcium 20 MG Oral TabletPSN7c3af5aa-2223-463a-e053-2a91aa0a16f910
859419rosuvastatin calcium 40 MG Oral TabletPSN7c3af5aa-2223-463a-e053-2a91aa0a16f910
859424rosuvastatin calcium 5 MG Oral TabletPSN7c3af5aa-2223-463a-e053-2a91aa0a16f910
859747rosuvastatin calcium 10 MG Oral TabletSCD7c3af5aa-2223-463a-e053-2a91aa0a16f910
859751rosuvastatin calcium 20 MG Oral TabletSCD7c3af5aa-2223-463a-e053-2a91aa0a16f910
859419rosuvastatin calcium 40 MG Oral TabletSCD7c3af5aa-2223-463a-e053-2a91aa0a16f910
859424rosuvastatin calcium 5 MG Oral TabletSCD7c3af5aa-2223-463a-e053-2a91aa0a16f910
859419rosuvastatin calcium 40 MG Oral TabletPSNd9b83920-26ae-462a-ac10-33fd1ed7738f8
859419rosuvastatin calcium 40 MG Oral TabletSCDd9b83920-26ae-462a-ac10-33fd1ed7738f8
859751rosuvastatin calcium 20 MG Oral TabletPSNdcc22d05-cff6-42f9-b9fa-930f2084753f2
859419rosuvastatin calcium 40 MG Oral TabletPSNdcc22d05-cff6-42f9-b9fa-930f2084753f2
859751rosuvastatin calcium 20 MG Oral TabletSCDdcc22d05-cff6-42f9-b9fa-930f2084753f2
859419rosuvastatin calcium 40 MG Oral TabletSCDdcc22d05-cff6-42f9-b9fa-930f2084753f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
27808-158-012780801580130 TABLET, FILM COATED in 1 BOTTLE (27808-158-01) 2018-01-080000-00-00NoNoCurrent
27808-158-02278080158021000 TABLET, FILM COATED in 1 BOTTLE (27808-158-02) 2025-05-01NoNoHistorical
27808-158-0327808015803500 TABLET, FILM COATED in 1 BOTTLE (27808-158-03) 2019-07-260000-00-00NoNoCurrent