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
Label	Manufacturer	Effective date	Type
Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium	Sandoz Inc \| Bayer HealthCare Pharmaceuticals Inc. \| Bayer Weimar GmbH und Co. KG \| Bayer AG \| Sharp Corporation	2023-05-19	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0781-4075-15	Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium	3 in 1 CARTON	KIT	3		14
0781-4075-52	Drospirenone/Ethinyl Estradiol/Levomefolate Calcium and Levomefolate Calcium	1 in 1 BLISTER PACK	KIT	1		14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-4075	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	14	Current NDC, Legacy NDC, 2 package rows	20241207_58cd12d3-39b1-4375-b7e0-09ba2378a52b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0781-4075-15	EA - Each	0781-4075	db0c01b5-770b-4c95-931c-d5eb9aea4154	1	2016-11-08
0781-4075-52	EA - Each	0781-4075	b1a3be2c-0e78-45ff-8fac-8dc6019b2027	1	2016-11-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DROSPIRENONE	ACTIVE INGREDIENT	N295J34A25	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
ETHINYL ESTRADIOL	ACTIVE INGREDIENT	423D2T571U	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
LEVOMEFOLATE CALCIUM	ACTIVE INGREDIENT	A9R10K3F2F	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
DROSPIRENONE	ACTIVE MOIETY	N295J34A25	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
ETHINYL ESTRADIOL	ACTIVE MOIETY	423D2T571U	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
LEVOMEFOLIC ACID	ACTIVE MOIETY	8S95DH25XC	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
BETADEX	INACTIVE INGREDIENT	JV039JZZ3A	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	DROSPIRENONE/ETHINYL ESTRADIOL/LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM KIT [SANDOZ INC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DROSPIRENONE/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 96 of 107 · 2,132 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DERMAKA Broad Spectrum SPF-42 Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	DERMAKA SKIN PRODUCTS	32b892fd-c68f-4670-bbaa-0b3de5712849	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
WILMA SCHUMANN Moisture Protektiv Day Cream SPF-20	OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE	SKINMETICS INC	4a719986-d1d0-4156-b803-04004b721504	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
DERMAKA Broad Spectrum SPF-42 Sunscreen Untinted	TITANIUM DIOXIDE, ZINC OXIDE	DERMAKA SKIN PRODUCTS	9aa24e1f-e338-4947-a437-554fb6b227a2	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
TRENDY JOHN SPF-32 Sheer Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	TRENDY JOHN LLC	80dccecb-fbb3-4af6-9cb4-6acea733e996	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
KOVR All-Natural SPF-30 Moisturizing Sunscreen for Women	TITANIUM DIOXIDE, ZINC OXIDE	ACTIVE LIFE INC	0ddc3bb9-595e-4ebd-ad3e-df4d94fd34ed	2023-11-11	Warnings	Exact identifier unii: 15FIX9V2JP
Personalized Day Moisturizer with SPF	TITANIUM DIOXIDE, ZINC OXIDE	Proven Skincare	3b6546ed-22ee-48e6-83cc-5cbadf567499	2023-11-10	Warnings	Exact identifier unii: 15FIX9V2JP
Tropical Sands SPF-30 Broad Spectrum Sunscreen (Coconut)	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	4935f888-cd92-61d1-e054-00144ff8d46c	2023-11-10	Warnings	Exact identifier unii: 15FIX9V2JP
Coral Safe SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	4925a507-863f-1088-e054-00144ff8d46c	2023-11-10	Warnings	Exact identifier unii: 15FIX9V2JP
CoralSafe Broad Spectrum SPF30	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands	e6e00896-b7e5-41c6-a72b-08e600758cf5	2023-11-10	Warnings	Exact identifier unii: 15FIX9V2JP
Coral Safe SPF-30 Broad Spectrum Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Elements Brands, Inc.	4925a3ad-6379-108a-e054-00144ff8d46c	2023-11-10	Warnings	Exact identifier unii: 15FIX9V2JP
BELASOL Sun Cream Non-Tinted Moisturizing SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	EK Clothing LLC dba Belasol	fb677ad0-2791-44ec-9720-951471ec009a	2023-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
Shaklee Youth Age Defense Mineral Moisturizer SPF 30	TITANIUM DIOXIDE	Shaklee Corporation	f4888fdc-09f9-43de-8c81-5a0f5e767d4e	2023-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
Spit and Polish Sun Smart Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Naturally Uncommon, LLC	af879a05-1483-5c11-e053-2995a90af45d	2023-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
EltaMD UV Active	ZINC OXIDE, TITANIUM DIOXIDE SUNSCREEN	CP Skin Health Group, Inc.	2c523aa0-7c34-4fc2-98a0-f2fdfe6d2cd2	2023-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
Physical Sunscreen SPF50 80 min WR 159-100	TITANIUM DIOXIDE, TITANIUM DIOXIDE SUNSCREEN	Swiss-American CDMO, LLC	0cca7b65-e24a-429c-b157-5f4e343424ab	2023-11-09	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	a20dc51a-1f6c-4a6d-97f6-2f048e0689a0	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0.5C	OCTISALATE, TITANIUM DIOXIDE	Guerlain	a6c8b20f-6377-443b-a89b-8b5d40c65ad8	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 0.5N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	b6591b2e-9e55-4f25-958c-f36f1ef85749	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1.5N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	6e2ae7cb-c390-4996-95e8-ae8fadefa8bd	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP
PARURE GOLD SKIN MATTE FOUNDATION NO-TRANSFER HIGH PERFECTION 24H CARE AND WEAR INFUSED WITH 24K GOLD AND WHITE PEONY WITH SUNSCREEN BROADSPECTRUM SPF 15 1N	OCTISALATE, TITANIUM DIOXIDE	Guerlain	a143c8cb-185c-4fd8-a901-3c0d9ffb8290	2023-11-08	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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