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 18 of 114 · 2,269 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 15COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.6b27df44-c441-4ae8-a1b0-a9cf2fff6f212026-01-21WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 17NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.3c295f6b-6202-a2e1-e063-6394a90a9a602026-01-21WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 19COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.b2eee48f-b644-403c-a57e-04a1491bc3862026-01-21WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.ebcc2c6c-a039-48d5-8c1c-5b347254c4c22026-01-21WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 21WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.6967f8bc-3092-44a9-926a-6c11676425e52026-01-21WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 23WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.37d4d8c1-e76b-48a3-9a13-f0543af1b28f2026-01-21WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 24WOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.fa5046f2-a6db-4ac3-a78f-1b5df075d7e82026-01-21WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 25NOCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.0c5fc63f-1899-4406-944a-1cdcdf8b42772026-01-21WarningsExact identifier
unii: 15FIX9V2JP
AGE20S SIGNATURE ESSENCE PACT INTENSE COVER 27COCTINOXATE, OCTOCRYLENE, TITANIUM DIOXIDEAekyung Industrial Co., Ltd.58a84ecd-3f27-40fc-8e0b-e29192679e6b2026-01-21WarningsExact identifier
unii: 15FIX9V2JP
sunscreenTITANIUM DIOXIDEGuangdong Zhoubang Biotechnology Co., Ltd48f13b1c-8104-881b-e063-6394a90a816d2026-01-21WarningsExact identifier
unii: 15FIX9V2JP
Welmedix HomeCare PRO Fragile Skin Dual Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEWelmedix LLC48da4589-0f5a-c25b-e063-6394a90ac18b2026-01-20WarningsExact identifier
unii: 15FIX9V2JP
KONEUK SUNSCREEN SPF50KONEUK SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.48dd7f6e-2a4d-2c92-e063-6294a90a42552026-01-20WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 2CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior12edec55-2414-4bbd-bc96-4599a96b96ac2026-01-19WarningsExact identifier
unii: 15FIX9V2JP
OUTER REEF MINERAL SUNSCREEN SPF 30TITANIUM DIOXIDECoral Reef Park Co., Inc.86ee2fdf-8a88-44e6-b12a-36a92360477a2026-01-19WarningsExact identifier
unii: 15FIX9V2JP
YuvafemESTRADIOLAvKAREd20abc9a-8f47-e274-c9b1-b71c9489761f2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
CURESHIELD MANICURE SUNSCREENZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD48b4fad7-073d-d983-e063-6394a90ae3142026-01-18WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0CR Cool FosyOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior65ff0448-17e6-42ce-989a-940794fcbd8c2026-01-17WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior04e9c4d8-1600-4ffc-8578-4ffb82b106f32026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5N NeutralOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1d6f10b7-60b9-47f6-9dba-1dd0a7cf6f5d2026-01-16WarningsExact identifier
unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5W WarmOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior1aae19da-1e73-41ed-91dc-0746ad311b872026-01-16WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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