FDA.reportPublic FDA data

NDC 43598-101-10 - 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
43598-101
Requested NDC
43598-101-10
Package NDCs from labels
43598-101-90, 43598-101-05, 43598-101-87, 43598-101-10, 43598-101-78
Manufacturer
REMEDYREPACK INC.
Effective date
2026-09-17
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Atorvastatin Calcium - REMEDYREPACK INC.REMEDYREPACK INC.2026-09-17HUMAN PRESCRIPTION DRUG LABEL
Atorvastatin Calcium - Dr. Reddy's Laboratories Inc | Dr. Reddy's Laboratories Limited FTO-Sez-Process Unit-01Dr. Reddy's Laboratories Inc | Dr. Reddy's Laboratories Limited FTO-Sez-Process Unit-012026-04-30HUMAN PRESCRIPTION DRUG LABEL
Atorvastatin Calcium - Coupler LLCCoupler LLC2024-11-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-101-05Atorvastatin Calcium500 in 1 BOTTLETABLET5004
43598-101-10Atorvastatin Calcium10 in 1 BLISTER PACKTABLET104
43598-101-78Atorvastatin Calcium10 in 1 CARTONTABLET104
43598-101-90Atorvastatin Calcium90 in 1 BOTTLETABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-101ATORVASTATIN CALCIUM TABLET [DR. REDDY'S LABORATORIES INC]4Current NDC, 4 package rows20240612_aaf960d1-8bf9-64c6-1e70-8aa33b0ce549.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-101-05EA - Each43598-1016c6afb59-2224-4e6b-84af-507743056e0c12024-09-09
43598-101-90EA - Each43598-10124aaa596-cf6f-4409-8c63-538d49e083ec12024-09-09

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 23 of 149 · 2,962 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atorvastatin CalciumATORVASTATIN CALCIUMSafecor Health, LLC6d552a6f-d7a2-4dba-8e71-2b97b4ee2faf2026-02-24Warnings, Adverse reactionsExact identifier
rxcui: 617311
rxcui: 617310
rxcui: 259255
rxcui: 617312
unii: 48A5M73Z4Q
SHISEIDO URBAN ENVIRONMENT MINERAL CLEAR SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEShiseido Americas Corporationb93f10dc-193d-4cda-94b6-3f0e54d89f212026-02-23WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO ULTIMATE SUN PROTECTOR MINERALTITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION5e31eee8-6532-47ea-99fc-22418791804b2026-02-23WarningsExact identifier
unii: 15FIX9V2JP
Perfect Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESKIN PERFECT MEDICAL4b47e7cb-17d6-6a7c-e063-6294a90abbea2026-02-20WarningsExact identifier
unii: 15FIX9V2JP
Calcium Carbonate 500 mgCALCIUM CARBONATENuCare Pharmaceuticals,Inc.bad70158-3890-7e98-e053-2995a90a9c1c2026-02-19WarningsExact identifier
unii: H0G9379FGK
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch Prepacke873d38c-4bda-4101-be98-85b1601d09f72026-02-18Warnings, Adverse reactionsExact identifier
rxcui: 617312
unii: 48A5M73Z4Q
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch Prepack1914264b-4c95-4066-91ca-b5c91d8b741e2026-02-18Warnings, Adverse reactionsExact identifier
rxcui: 259255
unii: 48A5M73Z4Q
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch Prepack5b9a5a36-7814-4d19-b146-01e819676ae22026-02-18Warnings, Adverse reactionsExact identifier
rxcui: 617310
unii: 48A5M73Z4Q
Allay Skin Solutions Protect Nourish Mineral Sunscreen SPF 42TITANIUM DIOXIDE, ZINC OXIDEALLAY SKIN SOLUTIONS LLC425bf1d7-f2cf-4237-9047-dd53054acd1c2026-02-18WarningsExact identifier
unii: 15FIX9V2JP
Hermes Plein Air-Baume de Teint Perfecteur Naturel-Enhancing Complexion Balm 85 TAMARINTITANIUM DIOXIDES.A. COMPTOIR NOUVEAU DE LA PARFUMERIEdacff3dc-49d7-6416-e053-2a95a90a85c62026-02-18WarningsExact identifier
unii: 15FIX9V2JP
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMA-S Medication Solutionsc8b186e4-28c2-4bf9-8964-5a5f3ca3a2da2026-02-17Warnings, Adverse reactionsExact identifier
rxcui: 617310
unii: 48A5M73Z4Q
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMA-S Medication Solutionsdb32eb1a-d282-47df-afa2-f250e3c67e712026-02-17Warnings, Adverse reactionsExact identifier
rxcui: 617310
unii: 48A5M73Z4Q
Amlodipine and AtorvastatinAMLODIPINE AND ATORVASTATINBryant Ranch Prepack043c4742-081d-4bc4-bf27-dad92bb2dfbc2026-02-12Warnings, Adverse reactionsExact identifier
unii: 48A5M73Z4Q
AfloraMULTIVITAMINOncora Pharma, LLC38e463d1-f608-7cb5-e063-6294a90a4abb2026-02-12Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
FolixiaMULTIVITAMINOncora Pharma, LLC413945b5-116b-d8b6-e063-6394a90a55e82026-02-12Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
NutralynMULTIVITAMINOncora Pharma, LLC33da017b-1e8c-d41c-e063-6394a90aab8c2026-02-12Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
FolatenMULTIVITAMINOncora Pharma, LLC93086235-2c33-424d-b0c3-2130319885812026-02-12Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
Alumier MD Clear Shield Broad Spectrum SPF 42 SunscreenTITANIUM DIOXIDE, ZINC OXIDEAlumier Labsa9c970c8-b6e3-b0a1-e053-2a95a90a89c72026-02-09WarningsExact identifier
unii: 15FIX9V2JP
Hampton Sun SPF 50 MineralZINC OXIDE 19.5% TITANIUM DIOXIDE 4.00%S&C Hampton Sun LLCd6c33436-042e-44e8-8b55-98be6e2468792026-02-06WarningsExact identifier
unii: 15FIX9V2JP
SHISEIDO WASO COLOR-SMART DAY MOISTURIZEROCTINOXATE, TITANIUM DIOXIDEShiseido Americas Corporationf291f077-1c72-48fc-bb19-c20bdeaaa5962026-02-06WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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