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 67 of 113 · 2,241 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Balance Plus CreamESTRIOL,ESTRADIOL,PROGESTERONE,DHEASHYNE BRANDS/BIOLabs PRO37e5e4ae-8cb1-19bb-e063-6294a90ac43d2025-06-01WarningsExact identifier
unii: 4TI98Z838E
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC31f1e961-3719-f70a-e063-6394a90a481e2025-05-31WarningsExact identifier
unii: 15FIX9V2JP
Estradiol Vaginal CreamESTRADIOLPrasco Laboratoriesc895ac14-5dbd-4201-bf3e-ba7c38a4e9942025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Dr. Mercola Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDENatural Health Partners, LLC47f6ab9e-fa73-496a-e054-00144ff8d46c2025-05-28WarningsExact identifier
unii: 15FIX9V2JP
Female StimulantLILIUM TIGRINUM, BOVISTA, CYPRIPEDIUM PUBESCENS, HYDRASTIS CANADENSIS, PETROSELINUM SATIVUM, AQUILEGIA VULGARIS, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEART (SUIS), KREOSOTUM, OOPHORINUM (SUIS), UTERUS (SUIS), FOLLICULINUM, LACHESIS MUTUS, MAGNESIA PHOSPHORICA, MERCURIUS SOLUBILIS, SEPIA, PINEAL GLAND (SUIS), HYPOPHYSIS SUIS, ACONITICUM ACIDUM CIS-, APIS VENENUM PURUM, ESTRADIOL, PROGESTERONE, TESTOSTERONE, PLACENTA TOTALIS SUIS, FAECALIS (ALKALIGENES), MUTABILE BACILLUS (BACH)Deseret Biologicals, Inc.18d072ec-93e1-4e20-82db-98e80b81c3632025-05-27WarningsExact identifier
unii: 4TI98Z838E
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
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
Vivier Sheer SPF 30 Mineral TintedTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma, Inc.e12e3bcb-4c3d-41be-8e2b-12a817c8b3672025-05-05WarningsExact identifier
unii: 15FIX9V2JP
EstradiolESTRADIOLAmerican Health Packaging265a1ee1-f314-4324-a2e1-0120a9a00a202025-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLPreferred Pharmaceuticals Inc.9956a196-fefd-4766-a225-e154fbd3aeff2025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EltaMD UV AOX ElementsZINC OXIDE, TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Incd01756c0-1f82-4e08-b956-8000ecaddfd12025-05-01WarningsExact identifier
unii: 15FIX9V2JP
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 PorcelainOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS2fbf7f9d-dba7-48f9-b10e-63225e8f13992025-04-25WarningsExact identifier
unii: 15FIX9V2JP
KARYNG Complete SPF Sunscreen Light/MediumSUNSCREENKaryng LLC33596253-413d-fba3-e063-6394a90a39e42025-04-22WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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