NDC 68788-7612-09 - 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
68788-7612
Requested NDC
68788-7612-09
Package NDCs from labels
68788-7612-2, 68788-7612-3, 68788-7612-6, 68788-7612-9, 68788-7612-09
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 Calcium - Preferred Pharmaceuticals, Inc.Preferred Pharmaceuticals, Inc.2026-08-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-7612-2Rosuvastatin Calcium20 in 1 BOTTLETABLET, FILM COATED206
68788-7612-3Rosuvastatin Calcium30 in 1 BOTTLETABLET, FILM COATED306
68788-7612-6Rosuvastatin Calcium60 in 1 BOTTLETABLET, FILM COATED606
68788-7612-9Rosuvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7612ROSUVASTATIN CALCIUM TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]5Current NDC, Legacy NDC, 4 package rows20240808_6ef51f7c-2899-4b09-bf8b-09e5b4ac3424.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
ndc (package): 68788-7612-2
ndc (package): 68788-7612-9
ndc (package): 68788-7612-6
ndc (package): 68788-7612-3
ndc (product): 68788-7612
ndc11 (package): 68788761209
rxcui: 859751
spl id: 5f979f26-fe2b-4e7c-931c-2a627c46c201
spl set id: 6ef51f7c-2899-4b09-bf8b-09e5b4ac3424
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.