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 95 of 147 · 2,923 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE AND ZINC OXIDEDERM ASSO. MID OHIO2d04bc5d-6f11-4f56-e063-6294a90ae7552025-01-31WarningsExact identifier
unii: 15FIX9V2JP
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2d0766a1-4091-e84a-e063-6394a90a004a2025-01-31WarningsExact identifier
unii: 15FIX9V2JP
Atorvastatin calciumATORVASTATIN CALCIUMBryant Ranch Prepack71cd9b85-4914-4b0b-97db-7aaf259832112025-01-31Warnings, Adverse reactionsExact identifier
rxcui: 617310
Atorvastatin CalciumATORVASTATIN CALCIUMBryant Ranch Prepack2035c49b-f319-4dce-bf1c-c2f64e786fb72025-01-31Warnings, Adverse reactionsExact identifier
rxcui: 617312
unii: 48A5M73Z4Q
Calcium Carbonate 1250 mgCALCIUM CARBONATECitraGen Pharmaceuticals, Inc.766b3f3f-8bd1-281c-e053-2991aa0af54b2025-01-30WarningsExact identifier
unii: H0G9379FGK
Calcium Carbonate 10 gr (648 mg)CALCIUM CARBONATECitraGen Pharmaceuticals, Inc.723b940d-4f4b-f2e6-e053-2991aa0a8bcc2025-01-30WarningsExact identifier
unii: H0G9379FGK
Atorvastatin calciumATORVASTATIN CALCIUMCoupler LLC2cd9999b-e18f-09de-e063-6294a90a108b2025-01-29Warnings, Adverse reactionsExact identifier
rxcui: 617312
unii: 48A5M73Z4Q
COVER plus CORRECT/TINTED MOISTURIZER CC CRM FAIROCTINOXATE, OCTISALATE, OXYBENZONE, AND TITANIUM DIOXIDEBluemercury5c590aed-d2f2-4478-8919-37c848752b422025-01-29WarningsExact identifier
unii: 15FIX9V2JP
LiProtect SPF 35ZINC OXIDE, TITANIUM DIOXIDEScience of Skincare0d0a2657-4098-3c60-e063-6294a90acabb2025-01-29WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBELLE MEDICAL LLC2cdc69d3-2192-7a38-e063-6294a90a257f2025-01-29WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEBoxbar Beauty LLC2d04c5e7-f3aa-873f-e063-6294a90a33d22025-01-29WarningsExact identifier
unii: 15FIX9V2JP
TiZO Mineral Sun Defense SPF 50TITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals Ltd.2cc8f7ef-eda3-fe71-e063-6394a90a6a9a2025-01-28WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZ&Z Skin Essentials2cdc48f3-474f-9c06-e063-6294a90afea12025-01-27WarningsExact identifier
unii: 15FIX9V2JP
Ultra Strength AntacidCALCIUM CARBONATECVS2bc4c71c-a9c5-17df-e063-6294a90ac88c2025-01-27WarningsExact identifier
unii: H0G9379FGK
Cetaphil Sheer Mineral Sunscreen Stick SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.54f6df65-e90c-4070-aa95-f47496dd11bd2025-01-27WarningsExact identifier
unii: 15FIX9V2JP
Atorvastatin calciumATORVASTATIN CALCIUMCoupler LLC2c67a15c-53b7-f431-e063-6394a90acc502025-01-25Warnings, Adverse reactionsExact identifier
rxcui: 617310
unii: 48A5M73Z4Q
CoTZ Silky Foam - TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDd63088d7-a1d7-4b56-a7d8-ad217011a8a82025-01-24WarningsExact identifier
unii: 15FIX9V2JP
CoTZ Silky Foam Non-TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD9c04b76e-ae65-4183-b475-3b8e8764db592025-01-24WarningsExact identifier
unii: 15FIX9V2JP
Atorvastatin CalciumATORVASTATIN CALCIUMCoupler LLC2c658654-87ee-b52a-e063-6294a90a11d62025-01-23Warnings, Adverse reactionsExact identifier
application number: ANDA214659
rxcui: 617310
unii: 48A5M73Z4Q
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMBryant Ranch Prepack49e0e9e7-447d-4d9d-847e-46d68a77db2d2025-01-21Warnings, Adverse reactionsExact identifier
rxcui: 259255
unii: 48A5M73Z4Q

Reported adverse events (FAERS/openFDA)#

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