NDC 68084-099-11 - 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
68084-099
Requested NDC
68084-099-11
Package NDCs from labels
68084-099-11, 68084-099-01
Manufacturer
American Health Packaging
Effective date
2026-09-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Atorvastatin Calcium - American Health PackagingAmerican Health Packaging2026-09-10HUMAN PRESCRIPTION DRUG LABEL
Atorvastatin Calcium - Cardinal Health 107, LLCCardinal Health 107, LLC2026-04-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-099-01Atorvastatin Calcium100 in 1 BOX, UNIT-DOSETABLET, FILM COATED10012
68084-099-11Atorvastatin Calcium1 in 1 BLISTER PACKTABLET, FILM COATED112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-099ATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]11Current NDC, Legacy NDC, 2 package rows20240904_6d203e05-1fe6-4262-9d66-b461f84c4672.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-099-01EA - Each68084-09960cc1db5-4896-431e-a764-4aa1aeaa1d5112013-10-17
68084-099-11EA - Each68084-0999bfcb073-c167-4333-9ec4-7555e6e8de4b12013-10-17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATEACTIVE INGREDIENTYRZ789OWMIATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
ATORVASTATIN CALCIUM PROPYLENE GLYCOL SOLVATEACTIVE INGREDIENTYRZ789OWMIATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
ATORVASTATINACTIVE MOIETYA0JWA85V8FATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
CALCIUM ACETATEINACTIVE INGREDIENTY882YXF34XATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
CALCIUM ACETATEINACTIVE INGREDIENTY882YXF34XATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
SODIUM CARBONATEINACTIVE INGREDIENT45P3261C7TATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [CARDINAL HEALTH]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPATORVASTATIN CALCIUM TABLET, FILM COATED [AMERICAN HEALTH PACKAGING]3

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 4 of 150 · 2,992 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
rxcui: 617310
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
SmogstatECHINACEA (ANGUSTIFOLIA), HYPERICUM PERFORATUM, HYDRASTIS CANADENSIS, SYMPHYTUM OFFICINALE, ARSENICUM ALBUM, CARBO VEGETABILIS, CAUSTICUM, KALI CARBONICUM, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEAEnergique, Inc.59f63e2b-24fa-43a0-8334-02e6729c6ac12026-07-31WarningsExact identifier
unii: ETJ7Z6XBU4
Muscle IcePHYTOLACCA DECANDRA, BELLIS PERENNIS, LEDUM PALUSTRE, RUTA GRAVEOLENS, SYMPHYTUM OFFICINALE, MAGNESIA PHOSPHORICA, SILICEA, MENTHOL (CRYSTALS)Peaceful Mountain, Inc.03b6e2a9-f335-4ae2-9011-80bd019afb722026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
BioplasmaSILICON DIOXIDE,POTASSIUM CHLORIDE,SODIUM SULFATE,FERROSOFERRIC PHOSPHATE,MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE,SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE,TRIBASIC CALCIUM PHOSPHATE,POTASSIUM PHOSPHATE, DIBASIC,POTASSIUM SULFATE,SODIUM CHLORIDE,CALCIUM SULFATE ANHYDROUS,CALCIUM FLUORIDEHyland's Inc.dd0a7ed2-d112-4b96-e053-2995a90ac6b62026-07-30WarningsExact identifier
unii: ETJ7Z6XBU4
Atorvastatin CalciumATORVASTATIN CALCIUMCardinal Health 107, LLCaee307d6-b3fa-424f-8656-1f30ff413e952026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 259255
ATORVASTATIN CALCIUMATORVASTATIN CALCIUMMajor Pharmaceuticalse74278b6-31fc-48d4-97b7-ba500e9e15fb2026-07-27Warnings, Adverse reactionsExact identifier
application number: ANDA090548
rxcui: 617311
rxcui: 259255
unii: YRZ789OWMI
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
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
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Atorvastatin calciumATORVASTATIN CALCIUMMacleods Pharmaceuticals Limited7bd0f0ec-f7a3-4403-9a1a-11f18213631f2026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 617311
rxcui: 617310
rxcui: 259255
rxcui: 617312
Atorvastatin CalciumATORVASTATIN CALCIUMDirect_Rx56a9e58f-567e-30cc-e063-6294a90a290f2026-07-15Warnings, Adverse reactionsExact identifier
rxcui: 617312
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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