FDA.reportPublic FDA data

NDC 50090-5634-01 - Atorvastatin 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
50090-5634
Requested NDC
50090-5634-01
Package NDCs from labels
50090-5634-1, 50090-5634-0, 50090-5634-01
Manufacturer
A-S Medication Solutions
Effective date
2023-02-06
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Atorvastatin Calcium - A-S Medication SolutionsA-S Medication Solutions2023-02-06HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-5634-02023-02-06These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
50090-5634-12023-02-06These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
50090-5634-02023-01-30These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996
50090-5634-12023-01-30These highlights do not include all the information needed to use ATORVASTATIN CALCIUM TABLETS safely and effectively. See full prescribing information for ATORVASTATIN CALCIUM TABLETS ATORVASTATIN CALCIUM tablets, for oral use Initial U.S. Approval: 1996

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5634-0Atorvastatin Calcium30 in 1 BOTTLETABLET303
50090-5634-1Atorvastatin Calcium90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5634ATORVASTATIN CALCIUM TABLET [A-S MEDICATION SOLUTIONS]3Current NDC, Legacy NDC, 2 package rows20230208_d3f27113-785c-419e-955a-d6782fade438.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5634-0EA - Each50090-5634803e0b8b-615b-4755-9e4b-b0f01b388a4112022-10-06
50090-5634-1EA - Each50090-5634e494b1f9-d9e5-44e6-911a-1f8f1d01ea1412022-10-06

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 2 of 179 · 3,563 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DG HEALTH Regular StrengthANTACID TABLETS (CALCIUM CARBONATE)DOLGENCORP, LLC13dd2758-a372-4b0e-bc99-56a2dacbf95f2026-09-03WarningsExact identifier
unii: H0G9379FGK
DG health Extra Strength Antacid Wintergreen flavorCALCIUM CARBONATEDOLGENCORP, LLCb84b3509-3178-4616-9bec-dad85a4f9d2a2026-09-03WarningsExact identifier
unii: H0G9379FGK
DG Health Regular Strength AntacidCALCIUM CARBONATEDOLGENCORP, LLC59ad3cc7-4144-442f-a37d-75c5fe23e1ae2026-09-03WarningsExact identifier
unii: H0G9379FGK
DG health Extra Strength Assorted Fruits AntacidCALCIUM CARBONATEDOLGENCORP, LLC112f1002-c007-4363-ade6-8dfbc61f4b642026-09-03WarningsExact identifier
unii: H0G9379FGK
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINApotex Corp.4c7b1b11-90a3-bc1c-0e45-9e2a14ef0b032026-09-03Warnings, Adverse reactionsExact identifier
unii: 48A5M73Z4Q
DG health Extra Strength AntacidSMOOTH DISSOLVE CALCIUM CARBONATEDOLGENCORP, LLCcabaa8f7-9c93-439d-905a-5ef643a08ea82026-09-03WarningsExact identifier
unii: H0G9379FGK
Kids AntacidCALCIUM CARBONATETHE KROGER CO.d77c629b-5308-4b71-9024-9899cf88dbae2026-09-01WarningsExact identifier
unii: H0G9379FGK
Kroger Extra Strength Smooth Antacid Assorted BerryCALCIUM CARBONATEKROGER COMPANY4c8d39d9-9d58-45df-9ffd-2cdc41539c032026-09-01WarningsExact identifier
unii: H0G9379FGK
Kroger Ultra Strength Assorted FruitCALCIUM CARBONATEKROGER COMPANYb60ced06-725c-4dae-abbf-21cab9e431f92026-08-31WarningsExact identifier
unii: H0G9379FGK
Kroger Extra Strength Sugar FreeCALCIUM CARBONATEKROGER COMPANY3f737ce2-961e-4bd0-ae6d-078248cf1c672026-08-31WarningsExact identifier
unii: H0G9379FGK
Kroger Extra Strength Assorted BerryCALCIUM CARBONATEKROGER COMPANYfa191237-d230-4528-8dff-50e8d5c65b6d2026-08-31WarningsExact identifier
unii: H0G9379FGK
BMNP SiliceaSILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro5a58454f-aed6-24ba-e063-6294a90a47fb2026-08-31WarningsExact identifier
unii: ETJ7Z6XBU4
Kroger Ultra Strength Assorted BerryCALCIUM CARBONATEKROGER COMPANYb7db77a7-0580-455b-a2ef-a68584f039812026-08-31WarningsExact identifier
unii: H0G9379FGK
Ultra Strength Natural AntacidCALCIUM CARBONATEKROGER COMPANY2931d427-b2be-4db9-a58d-ff89c221ff512026-08-31WarningsExact identifier
unii: H0G9379FGK
Ultra Strength AntacidANTACID TABLETSTHE KROGER CO.,f5d82d1b-2f75-4af4-8337-a5bd28c26fb72026-08-31WarningsExact identifier
unii: H0G9379FGK
Kroger Extra Strength Assorted FruitCALCIUM CARBONATEKROGER COMPANY486d7a5f-cbc8-4f86-b12e-c5325bd8c62d2026-08-31WarningsExact identifier
unii: H0G9379FGK
Atorvastatin CalciumATORVASTATIN CALCIUMREMEDYREPACK INC.57f9b462-f08e-483c-9b64-b7e4c8d469272026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 617312
unii: 48A5M73Z4Q
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Argentum QuartzARGENTUM QUARTZUriel Pharmacy Inc.765c8c8f-0727-45da-a77e-c3907a3d07932026-08-26WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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