FDA.reportPublic FDA data

NDC 68788-8533-06 - Rosuvastatin

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
68788-8533
Requested NDC
68788-8533-06
Package NDCs from labels
68788-8533-2, 68788-8533-3, 68788-8533-6, 68788-8533-9, 68788-8533-06
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-08-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rosuvastatin - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2026-08-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8533-2Rosuvastatin20 in 1 BOTTLETABLET, FILM COATED203
68788-8533-3Rosuvastatin30 in 1 BOTTLETABLET, FILM COATED303
68788-8533-6Rosuvastatin60 in 1 BOTTLETABLET, FILM COATED603
68788-8533-9Rosuvastatin90 in 1 BOTTLETABLET, FILM COATED903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8533ROSUVASTATIN TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 4 package rows20240808_979588e5-d266-4728-aa58-36cd6a217584.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8533-2EA - Each68788-8533478ddbaa-2c74-4a11-9ae2-45b34143f61512023-12-05
68788-8533-3EA - Each68788-853339c4f1fd-1302-40c1-91a9-2542a8e4172512023-12-05
68788-8533-6EA - Each68788-85335fccc5b1-900f-4b5c-add8-1ae7748af00d12023-12-05
68788-8533-9EA - Each68788-85335c6b6699-bb85-47ce-8ded-b4c7d270331a12023-12-05

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 122 · 2,435 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
Xtreme Saline Rinse MixSODIUM BICARBONATE, SODIUM CHLORIDEXtreme Personal Care Inc776f417e-e443-4918-8c7a-1913b7dddcd42026-09-01WarningsExact identifier
unii: 8MDF5V39QO
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
Sodium BicarbonateSODIUM BICARBONATEREMEDYREPACK INC.96093b76-5d98-4d2b-b851-20207a8864db2026-08-28Warnings, Adverse reactionsExact identifier
unii: 8MDF5V39QO
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
application number: ANDA207616
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

Reported adverse events (FAERS/openFDA)#

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