FDA.reportPublic FDA data

NDC 71335-1017-05 - Rosuvastatin Calcium

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
71335-1017
Requested NDC
71335-1017-05
Package NDCs from labels
71335-1017-1, 71335-1017-2, 71335-1017-3, 71335-1017-4, 71335-1017-5, 71335-1017-05
Manufacturer
Bryant Ranch Prepack
Effective date
2024-05-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rosuvastatin Calcium - Bryant Ranch PrepackBryant Ranch Prepack2024-05-17HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71335-1017-12024-05-17These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
71335-1017-22024-05-17These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
71335-1017-32024-05-17These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
71335-1017-42024-05-17These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
71335-1017-12024-01-30These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
71335-1017-22024-01-30These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
71335-1017-32024-01-30These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003
71335-1017-42024-01-30These highlights do not include all the information needed to use ROSUVASTATIN TABLETS safely and effectively. See full prescribing information for ROSUVASTATIN TABLETS. ROSUVASTATIN tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1017-1Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED309
71335-1017-2Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED909
71335-1017-3Rosuvastatin Calcium28 in 1 BOTTLETABLET, FILM COATED289
71335-1017-4Rosuvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED609
71335-1017-5Rosuvastatin Calcium100 in 1 BOTTLETABLET, FILM COATED1009

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1017ROSUVASTATIN CALCIUM TABLET, FILM COATED [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 5 package rows20240518_d6645266-9626-430e-bf04-b6426525ae0a.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 112 · 2,240 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Rosuvastatin calciumROSUVASTATIN CALCIUMREMEDYREPACK INC.cb942007-6ef1-4445-8dbd-6f4972148bf12026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 859747
unii: 83MVU38M7Q
RosuvastatinROSUVASTATINScieGen Pharmaceuticals, Inc.ee4933c5-0d97-494d-ac0f-2083e01008362026-09-04Warnings, Adverse reactionsExact identifier
rxcui: 859424
rxcui: 859751
rxcui: 859419
rxcui: 859747
RosuvastatinROSUVASTATINREMEDYREPACK INC.a370a6c2-b5cd-4aa0-b072-a5a8017a2d5b2026-09-04Warnings, Adverse reactionsExact identifier
rxcui: 859419
RosuvastatinROSUVASTATINREMEDYREPACK INC.ab8f6264-cf12-4523-92f1-2bd60b3da4422026-09-03Warnings, Adverse reactionsExact identifier
rxcui: 859751
RosuvastatinROSUVASTATINREMEDYREPACK INC.b8b29392-85fa-417b-bd10-10ab0d07381f2026-09-03Warnings, Adverse reactionsExact identifier
rxcui: 859747
Rosuvastatin CalciumROSUVASTATIN CALCIUMTORRENT PHARMACEUTICALS LIMITED6985e729-d963-4f32-89a1-727472b86daa2026-09-02Warnings, Adverse reactionsExact identifier
rxcui: 859424
rxcui: 859751
rxcui: 859419
rxcui: 859747
unii: 83MVU38M7Q
Rosuvastatin CalciumROSUVASTATIN CALCIUMRising Pharma Holdings, Inc.5c992d3d-d754-48b6-a267-1451208352ed2026-09-01Warnings, Adverse reactionsExact identifier
rxcui: 859424
rxcui: 859751
rxcui: 859419
rxcui: 859747
unii: 83MVU38M7Q
Rosuvastatin calciumROSUVASTATIN CALCIUMREMEDYREPACK INC.c607da3c-47f5-4773-8391-2a7b0826d30e2026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 859751
unii: 83MVU38M7Q
Rosuvastatin calciumROSUVASTATIN CALCIUMREMEDYREPACK INC.f230f4fe-0dbd-4062-9e11-a3e74bcdcba82026-08-31Warnings, Adverse reactionsExact identifier
rxcui: 859419
unii: 83MVU38M7Q
Rosuvastatin CalciumROSUVASTATIN CALCIUMAurobindo Pharma Limited47924917-bbd5-45de-96cb-c7ff9754da972026-08-28Warnings, Adverse reactionsExact identifier
rxcui: 859424
rxcui: 859751
rxcui: 859419
rxcui: 859747
unii: 83MVU38M7Q
RosuvastatinROSUVASTATINREMEDYREPACK INC.6ebaefa9-2c71-4777-8730-83cf5ae737cc2026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 859424
Rosuvastatin calciumROSUVASTATIN CALCIUMREMEDYREPACK INC.94245f53-2892-4209-8c94-c32c87d5b1062026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 859747
unii: 83MVU38M7Q
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
RosuvastatinROSUVASTATINPreferred Pharmaceuticals Inc.92a58577-b549-4143-abd0-391a07ed714d2026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 859419
unii: 83MVU38M7Q
RosuvastatinROSUVASTATINPreferred Pharmaceuticals Inc.d91dd29a-bb29-4193-a849-840f8696f6582026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 859751
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Rosuvastatin CalciumROSUVASTATIN CALCIUMPreferred Pharmaceuticals, Inc.6ef51f7c-2899-4b09-bf8b-09e5b4ac34242026-08-26Warnings, Adverse reactionsExact identifier
application number: ANDA208898
rxcui: 859751
unii: 83MVU38M7Q
Rosuvastatin CalciumROSUVASTATIN CALCIUMPreferred Pharmaceuticals Inc.b94b5b36-c04e-45ee-b933-59c4302f26612026-08-26Warnings, Adverse reactionsExact identifier
application number: ANDA208898
rxcui: 859747
unii: 83MVU38M7Q
Rosuvastatin calciumROSUVASTATIN CALCIUMPreferred Pharmaceuticals Inc.,e432e043-c019-4d58-94ca-7c1d85f5cd402026-08-26Warnings, Adverse reactionsExact identifier
rxcui: 859424
unii: 83MVU38M7Q

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.