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 50 of 107 · 2,136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Silk ScreenTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c44baf4-9555-faad-e063-6294a90ab24f2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Glow StickTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c54b857-c017-a953-e063-6394a90a38df2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Lip ShieldTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c545e55-3f55-842b-e063-6394a90ae48e2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Bare Barrier SportTITANIUM DIOXIDE, ZINC OXIDESkin Apeel, Inc.3c580794-eda3-de57-e063-6294a90a03032025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Flawless Brightening SunscreenTITANIUM DIOXIDE, ZINC OXIDEFlawless Skin Care LLC312e9ca0-a388-a546-e063-6294a90a15d62025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral SPF 40, protectTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2f8859cf-8277-6ea9-e063-6294a90a1a752025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral SPF 40, TintedTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2fb19ed7-8cee-ce80-e063-6394a90ad3dc2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral SPF 40, TintedTITANIUM DIOXIDE, ZINC OXIDEAcne Specialists LLC2fb14c4f-a435-aa6e-e063-6394a90a7d8d2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen SPF 40 Non-TintedTITANIUM DIOXIDE, ZINC OXIDESkin Restoration Aesthetics2fc4f701-eea2-7913-e063-6294a90a86932025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Mineral Sunscreen SPF 40 TintedTITANIUM DIOXIDE, ZINC OXIDESkin Restoration Aesthetics2fc55e8c-41d6-15cc-e063-6394a90ac5432025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Daily Tinted Mineral SPFTITANIUM DIOXIDE, ZINC OXIDESkin Restoration Aesthetics2fc6e168-b2c1-bf9d-e063-6394a90aade72025-12-08WarningsExact identifier
unii: 15FIX9V2JP
UV Shade tinted matte mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDEJoyce Kelly Enterprises365b3a1e-8410-da06-e063-6294a90a462f2025-12-08Exact identifier
unii: 15FIX9V2JP
Solar Shield non-tinted matte mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDEJoyce Kelly Enterprises365b68a0-0f89-0f43-e063-6294a90a5eee2025-12-08Exact identifier
unii: 15FIX9V2JP
Mineral Sunscreen tintedTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3000a0a7-2b51-b832-e063-6294a90a4a082025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Non-Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3001028b-bb36-04ec-e063-6294a90a1e492025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC3001aa3a-cc8b-6ad4-e063-6394a90a223f2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEFace 5, LLC300268ff-f9ef-1006-e063-6294a90a5fdf2025-12-08WarningsExact identifier
unii: 15FIX9V2JP
Clear Path Tinted Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDELULUS SPA BOUTIQUE37657755-fa82-88a0-e063-6394a90ade472025-12-08Exact identifier
unii: 15FIX9V2JP
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEDermacare376468ce-8d9b-b672-e063-6294a90a0bd12025-12-08Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEDermacare37643884-f186-fb54-e063-6394a90a450f2025-12-08Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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