NDC 0781-4075-52 - Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate 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
0781-4075
Requested NDC
0781-4075-52
Package NDCs from labels
0781-4075-52, 0781-4075-15
Manufacturer
Sandoz Inc | Bayer HealthCare Pharmaceuticals Inc. | Bayer Weimar GmbH und Co. KG | Bayer AG | Sharp Corporation
Effective date
2023-05-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate CalciumSandoz Inc | Bayer HealthCare Pharmaceuticals Inc. | Bayer Weimar GmbH und Co. KG | Bayer AG | Sharp Corporation2023-05-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-4075-15Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium3 in 1 CARTONKIT314
0781-4075-52Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium1 in 1 BLISTER PACKKIT114

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-4075DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]14Current NDC, Legacy NDC, 2 package rows20241207_58cd12d3-39b1-4375-b7e0-09ba2378a52b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-4075-15EA - Each0781-4075db0c01b5-770b-4c95-931c-d5eb9aea415412016-11-08
0781-4075-52EA - Each0781-4075b1a3be2c-0e78-45ff-8fac-8dc6019b202712016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DROSPIRENONEACTIVE INGREDIENTN295J34A25DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]1
ETHINYL ESTRADIOLACTIVE INGREDIENT423D2T571UDROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]1
LEVOMEFOLATE CALCIUMACTIVE INGREDIENTA9R10K3F2FDROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]1
DROSPIRENONEACTIVE MOIETYN295J34A25DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]1
ETHINYL ESTRADIOLACTIVE MOIETY423D2T571UDROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]1
LEVOMEFOLIC ACIDACTIVE MOIETY8S95DH25XCDROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]1
BETADEXINACTIVE INGREDIENTJV039JZZ3ADROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTDROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PDROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]1
TALCINACTIVE INGREDIENT7SEV7J4R1UDROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]1

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 64 of 107 · 2,132 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Solar SPF 40 Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences6ce602bb-c1f4-43c1-ae61-0f05d7952db32025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Solar stick Tinted SPF 40 Tinted Broad Spectrum SPF 40 Water Resistant (80 min) Mineral SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciencesb8f08778-7e5e-4341-9a24-1ce57c6525c72025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Nemah SPF 30 Mineral C/S Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDENemah, Inc.36da2d94-fa90-b145-e063-6394a90a58542025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral KidStick SPF 40 Mineral Broad Spectrum SPF 40 Sunscreen UVA-UVB SuncreenTITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences4c7f0257-fa12-40d6-9516-824b0e3a182c2025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Mineral KidCreme SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMDSolarSciences9ec56c68-6fea-444b-aeed-0b5d60c42e752025-06-05WarningsExact identifier
unii: 15FIX9V2JP
Aveeno Calm Plus Restore Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE, ZINC OXIDEKenvue Brands LLCfbf8be03-93e2-4d7e-e053-6294a90a4fd52025-06-04WarningsExact identifier
unii: 15FIX9V2JP
Age Defense for Eyes 5 in 1ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.48d5343a-1068-4c64-a275-c180026d69472025-06-03WarningsExact identifier
unii: 15FIX9V2JP
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC31f1e961-3719-f70a-e063-6394a90a481e2025-05-31WarningsExact identifier
unii: 15FIX9V2JP
Dr. Mercola Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDENatural Health Partners, LLC47f6ab9e-fa73-496a-e054-00144ff8d46c2025-05-28WarningsExact identifier
unii: 15FIX9V2JP
Protect Daily Ritual Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35ce8307-387b-2b40-e063-6294a90a28bc2025-05-23Exact identifier
unii: 15FIX9V2JP
Insecticides/Pest/Food Additives DetoxBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDr. Donna Restivo DCb5778211-0e3e-44ef-bd65-a76a68cf15042025-05-23WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bea4f3-c19e-3e2e-e063-6394a90aeb692025-05-22Exact identifier
unii: 15FIX9V2JP
Mineral Stick Non-TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595149d-0735-6bea-e063-6394a90a618a2025-05-20Exact identifier
unii: 15FIX9V2JP
Mineral Stick TintedTITANIUM DIOXIDE, ZINC OXIDEIT INTELLIGENT TREATMENT LLC3595735e-c25f-eb48-e063-6294a90aac0f2025-05-20Exact identifier
unii: 15FIX9V2JP
MultivitaminMULTIVITAMINPureTek Corporation353453e2-1f60-24ea-e063-6394a90a251e2025-05-15Warnings, Adverse reactionsExact identifier
unii: A9R10K3F2F
Prenate PixieASCORBIC ACID, BIOTIN, CHOLECALCIFEROL, CYANOCOBALAMIN, LEVOMEFOLATE CALCIUM, FOLIC ACID, FERROUS ASPARTO GLYCINATE, POTASSIUM IODIDE, PYRIDOXINE HYDROCHLORIDE, .ALPHA.-TOCOPHEROL ACETATE, DL-, DOCOSAHEXAENOIC ACID, AND BLUEBERRYAvion Pharmaceuticals, LLCfe0a737e-4f28-40d8-b4a7-090edf86a8232025-05-14Boxed warning, Adverse reactionsExact identifier
unii: A9R10K3F2F
Bright Guard Sport SPFZINC SPFRENU LABORATORIES, LLCc9b48a9e-d69f-65a7-e053-2995a90a0baf2025-05-12WarningsExact identifier
unii: 15FIX9V2JP
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6aa46-657b-2676-e063-6294a90abadd2025-05-09Exact identifier
unii: 15FIX9V2JP
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a5a99f-9e22-52ab-e063-6294a90a93232025-05-08Exact identifier
unii: 15FIX9V2JP
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
unii: 15FIX9V2JP
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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