FDA.reportPublic FDA data

NDC 50419-482-01 - Angeliq

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
50419-482
Requested NDC
50419-482-01
Package NDCs from labels
50419-482-01, 50419-482-03, 50419-482-71, 50419-482-72
Manufacturer
Bayer HealthCare Pharmaceuticals Inc.
Effective date
2026-03-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Angeliq - Bayer HealthCare Pharmaceuticals Inc.Bayer HealthCare Pharmaceuticals Inc.2026-03-02HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50419-482-01Angeliq28 in 1 BLISTER PACKTABLET, FILM COATED2820
50419-482-03Angeliq3 in 1 CARTONTABLET, FILM COATED320
50419-482-71Angeliq14 in 1 BLISTER PACKTABLET, FILM COATED1420
50419-482-72Angeliq1 in 1 CARTONTABLET, FILM COATED120

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-482ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 4 package rows20240207_761834c2-6b61-4583-84c2-f1ca4a97c4f2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-482-01EA - Each50419-482076940b1-c9d4-4296-8cd3-5c9088b6d11b12012-07-24
50419-482-03EA - Each50419-48230e00b9b-4994-4ff2-8b97-f6434d6d2d6212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DROSPIRENONEACTIVE INGREDIENTN295J34A25ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
ESTRADIOLACTIVE INGREDIENT4TI98Z838EANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
DROSPIRENONEACTIVE MOIETYN295J34A25ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
ESTRADIOLACTIVE MOIETY4TI98Z838EANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35ANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
TALCINACTIVE INGREDIENT7SEV7J4R1UANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]7
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPANGELIQ (DROSPIRENONE AND ESTRADIOL) TABLET, FILM COATED [BAYER HEALTHCARE PHARMACEUTICALS INC.]7

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 76 of 113 · 2,241 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Revlon Youth FXZINC OXIDE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corp442dec1e-032c-28de-e054-00144ff8d46c2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Almay Smart Shade Skintone Matching Makeup MediumTITANIUM DIOXIDE ZINC OXIDEAlmay, Inc.2a971e38-af63-e069-e063-6294a90a8f772024-12-31WarningsExact identifier
unii: 15FIX9V2JP
REVLON AGE DEFYING FIRMING LIFTING MAKEUP SPF 15OCTINOXATE, TITANIUM DIOXIDE MAKE-UPRevlon Consumer Products Corpd9209277-469d-48f4-bf64-f39a70c195962024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Almay Smart Shade Skintone Matching Makeup LightTITANIUM DIOXIDE ZINC OXIDEAlmay, Inc.2a987b85-efdb-eb95-e063-6394a90aef812024-12-31WarningsExact identifier
unii: 15FIX9V2JP
ALMAY SMART SHADE ANTI-AGING SKINTONE MATCHING MAKEUP SPF 20 LightTITANIUM DIOXIDE, ZINC OXIDEAlmay, Inc.2a984dd9-7293-77f0-e063-6294a90a8f1e2024-12-31WarningsExact identifier
unii: 15FIX9V2JP
Almay Healthy Biome MakeupHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEAlmayab20969a-8640-307d-e053-2a95a90a004d2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
EXEL CLARIFYING LINE DAILY FLUID SUN SHIELD WALNUT BROWN COLOR BROAD SPECTRUM SPF 60 PLUSOCTOCRYLENE, OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ENSULIZOLEExelencia importers Corp.2a845e4c-86e7-1799-e063-6294a90a9b2b2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Sheer Physical UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc2035ab03-80b4-49f4-b379-eb8bc42c9cee2024-12-30WarningsExact identifier
unii: 15FIX9V2JP
EstradiolESTRADIOLA-S Medication Solutionsf7e8dd35-c12f-46be-96f9-bf9a9b6f9a902024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
SkinCeuticals Physical Matte UV Defense Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Incb137b3d0-212b-440a-b158-62ace4b4eff32024-12-30WarningsExact identifier
unii: 15FIX9V2JP
SkinCeuticals Physical UV Defense Broad Spectrum SPF 30 SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc3a6db7d3-6c59-4633-a97e-1c03127246d32024-12-30WarningsExact identifier
unii: 15FIX9V2JP
EstradiolESTRADIOLA-S Medication Solutions41f424ec-9d08-4fda-b21d-41e92da6e1f02024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Kiehls Since 1851 Activated Sun Protector For Face and Body Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDEL'Oreal USA Products Inc87496037-36ca-4c5f-973f-46626cf4096e2024-12-27WarningsExact identifier
unii: 15FIX9V2JP
RODAN and FIELDS UNBLEMISHTITANIUM DIOXIDE, ZINC OXIDEBentley Laboratories, LLC2b3b6b62-364f-4aba-8024-3a73752b4c562024-12-27WarningsExact identifier
unii: 15FIX9V2JP
NORWEX Protect Prevent Mineral Facial Sunscreen Broad Spectrum SPF30TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, CORPORATION0d489154-6168-977e-e063-6394a90aa6092024-12-26WarningsExact identifier
unii: 15FIX9V2JP
CITY BLOCK SHEER Oil FREE DAILY FACE PROTECTOR BROAD SPECTRUM SPF 25TITANIUM DIOXIDE AND ZINC OXIDECLINIQUE LABORATORIES LLCee7e2ded-b850-4e15-96a6-556111e521872024-12-25WarningsExact identifier
unii: 15FIX9V2JP
CLINIQUE SUPER DEFENSE CITY BLOCK DAILY ENERGY PLUS FACE PROTECTOR BROAD SPECTRUM SPF 50OCTINOXATE, TITANIUM DIOXIDE, AND ZINC OXIDECLINIQUE LABORATORIES LLCd1a3d76f-16dd-4533-8144-9a3175f6e15f2024-12-25WarningsExact identifier
unii: 15FIX9V2JP
DOUBLE WEAR MAXIMUM COVER CAMOUFLAGE MAKEUP FOR FACE AND BODY BROAD SPECTRUM SPF 15TITANIUM DIOXIDEESTEE LAUDER INCa04a9aaa-fa0f-4dde-a7a5-c4c561cc51b12024-12-25WarningsExact identifier
unii: 15FIX9V2JP
STUDIO FIX FLUID SPF 15 BROAD SPECTRUMOCTINOXATE AND TITANIUM DIOXIDEMAKEUP ART COSMETICSff48435d-245a-4037-9afb-caee83c4c4152024-12-25WarningsExact identifier
unii: 15FIX9V2JP
ORIGINS GINZING ENERGY-BOOSTING TINTED MOISTURIZER BROAD SPECTRUM SPF 40OCTINOXATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, AND ZINC OXIDEORIGINS NATURAL RESOURCES INC.0fe63edf-7a49-4b33-88f1-f480f889d1942024-12-25WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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