FDA.reportPublic FDA data

NDC 63629-7158-05 - 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
63629-7158
Requested NDC
63629-7158-05
Package NDCs from labels
63629-7158-1, 63629-7158-2, 63629-7158-3, 63629-7158-4, 63629-7158-5, 63629-7158-05
Manufacturer
Bryant Ranch Prepack
Effective date
2024-10-08
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 Prepack2024-10-08HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63629-7158-12020-10-16These 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
63629-7158-22020-10-16These 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
63629-7158-32020-10-16These 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
63629-7158-42020-10-16These 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
63629-7158-12020-01-31These 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
63629-7158-22020-01-31These 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
63629-7158-32020-01-31These 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
63629-7158-42020-01-31These 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
63629-7158-1Rosuvastatin Calcium30 in 1 BOTTLETABLET, COATED3014
63629-7158-2Rosuvastatin Calcium90 in 1 BOTTLETABLET, COATED9014
63629-7158-3Rosuvastatin Calcium28 in 1 BOTTLETABLET, COATED2814
63629-7158-4Rosuvastatin Calcium60 in 1 BOTTLETABLET, COATED6014
63629-7158-5Rosuvastatin Calcium100 in 1 BOTTLETABLET, COATED10014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7158ROSUVASTATIN CALCIUM TABLET, COATED [BRYANT RANCH PREPACK]14Current NDC, Legacy NDC, 5 package rows20241023_1c97c9da-687b-47c1-9b9e-61f9a37bb9c4.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 110 · 2,192 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
rxcui: 859751
unii: 83MVU38M7Q
Rosuvastatin CalciumROSUVASTATIN CALCIUMPreferred Pharmaceuticals Inc.b94b5b36-c04e-45ee-b933-59c4302f26612026-08-26Warnings, Adverse reactionsExact identifier
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.