FDA.reportPublic FDA data

NDC 67877-511-33 - 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
67877-511
Requested NDC
67877-511-33
Package NDCs from labels
67877-511-90, 67877-511-05, 67877-511-10, 67877-511-55, 67877-511-33, 67877-511-38
Manufacturer
REMEDYREPACK INC.
Effective date
2026-08-27
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.2026-08-27HUMAN PRESCRIPTION DRUG LABEL
Atorvastatin Calcium - Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEMAsclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM2025-05-15HUMAN PRESCRIPTION DRUG LABEL
Atorvastatin Calcium - Ascend Laboratories, LLC | Alkem Laboratories LimitedAscend Laboratories, LLC | Alkem Laboratories Limited2025-04-29Human Prescription Drug Label
Atorvastatin Calcium - Bryant Ranch PrepackBryant Ranch Prepack2025-01-31HUMAN PRESCRIPTION DRUG LABEL
Atorvastatin Calcium - Preferred Pharmaceuticals Inc.Preferred Pharmaceuticals Inc.2025-01-03HUMAN PRESCRIPTION DRUG LABEL
Atorvastatin Calcium - Coupler LLCCoupler LLC2024-11-11HUMAN PRESCRIPTION DRUG LABEL
Atorvastatin Calcium - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-06-18HUMAN PRESCRIPTION DRUG LABEL
Atorvastatin Calcium - A-S Medication SolutionsA-S Medication Solutions2024-04-10Human Prescription Drug Label
Atorvastatin Calcium - RPK Pharmaceuticals, Inc.RPK Pharmaceuticals, Inc.2023-09-11Human Prescription Drug Label
Atorvastatin Calcium - A-S Medication SolutionsA-S Medication Solutions2021-03-02Human Prescription Drug Label
Atorvastatin Calcium - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2021-02-17HUMAN PRESCRIPTION DRUG LABEL
Atorvastatin Calcium - Denton Pharma, Inc. DBA Northwind PharmaceuticalsDenton Pharma, Inc. DBA Northwind Pharmaceuticals2020-01-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-511-05Atorvastatin Calcium500 in 1 BOTTLETABLET, FILM COATED50024
67877-511-10Atorvastatin Calcium1000 in 1 BOTTLETABLET, FILM COATED100024
67877-511-33Atorvastatin Calcium10 in 1 BLISTER PACKTABLET, FILM COATED1024
67877-511-38Atorvastatin Calcium10 in 1 CARTONTABLET, FILM COATED1024
67877-511-55Atorvastatin Calcium5000 in 1 BOTTLETABLET, FILM COATED500024
67877-511-90Atorvastatin Calcium90 in 1 BOTTLETABLET, FILM COATED9024

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-511ATORVASTATIN CALCIUM TABLET, FILM COATED [ASCEND LABORATORIES, LLC]24Current NDC, Legacy NDC, 6 package rows20250507_67e60880-091a-4df7-8696-6e6c42a490e2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-511-05EA - Each67877-511dc9a3bc4-51b3-4248-aa3c-fe3f9bd5a97412019-09-05
67877-511-10EA - Each67877-51139cc4e63-b693-49b7-906a-5a72ff13494212019-02-13
67877-511-90EA - Each67877-51181b8e478-87a8-40e9-bcd1-5b3a180b07d612019-02-13

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 5 of 147 · 2,933 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.b0bbab86-6789-4ffb-8f84-ee91b69fdb342026-08-06Warnings, Adverse reactionsExact identifier
rxcui: 617310
unii: 48A5M73Z4Q
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Atorvastatin calciumATORVASTATIN CALCIUMREMEDYREPACK INC.9786388d-ac8d-4646-9fe4-b33e8fda86b22026-08-05Warnings, Adverse reactionsExact identifier
rxcui: 617311
unii: 48A5M73Z4Q
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Atorvastatin CalciumATORVASTATIN CALCIUMREMEDYREPACK INC.09cb8375-075c-47e8-a4eb-8ac667ed849e2026-07-31Warnings, Adverse reactionsExact identifier
application number: ANDA209288
rxcui: 617310
unii: 48A5M73Z4Q
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Atorvastatin CalciumATORVASTATIN CALCIUMCardinal Health 107, LLCaee307d6-b3fa-424f-8656-1f30ff413e952026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 259255
unii: 48A5M73Z4Q
DUAL ACTION COMPLETEFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEAmazon.com Services LLC4e8a936c-b876-4923-ad9e-d23537b5d7cf2026-07-28WarningsExact identifier
unii: H0G9379FGK
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor Pharmaceuticalse74278b6-31fc-48d4-97b7-ba500e9e15fb2026-07-27Warnings, Adverse reactionsExact identifier
rxcui: 617311
rxcui: 259255
TUMS ULTRACALCIUM CARBONATEHaleon US Holdings LLC348d3dfa-6a52-4583-96e3-83c4bf2df45b2026-07-27WarningsExact identifier
unii: H0G9379FGK
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDEKenvue Brands LLCa2ef8424-7d80-42b0-a01e-f378f629b2b62026-07-24WarningsExact identifier
unii: H0G9379FGK
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
Atorvastatin CalciumATORVASTATIN CALCIUMCardinal Health 107, LLCfbd1c5da-67fb-4412-acb5-4d4c74a436542026-07-24Warnings, Adverse reactionsExact identifier
rxcui: 259255
unii: 48A5M73Z4Q
PRENATE RestoreASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, DL-, FOLIC ACID, PYRIDOXINE HYDROCHLORIDE, CYANOCOBALAMIN, BIOTIN, CALCIUM CARBONATE, FERROUS FUMARATE, MAGNESIUM OXIDE, LACTIC ACID AND DOCONEXENTAvion Pharmaceuticals, LLC1076ba9a-0168-492f-ba9b-99fa021860922026-07-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
unii: 6OZP39ZG8H
PNV-OmegaASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENTAcella Pharmaceuticals, LLC735c5531-137f-4cee-8c68-ae121045a8ff2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H0G9379FGK
COMPLETE ACID REDUCERFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED962ced24-0fb3-4aba-b32e-2e6fa1c1c5d72026-07-22WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

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