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 94 of 107 · 2,132 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
3LAB PERFECT BB SPF 40 Broad Spectrum 02	TITANIUM DIOXIDE	3LAB, Inc	bf4419b9-408d-469a-aa15-bbf419632f02	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Likewise Facial Moisturizer - Sun Protectant SPF 50 Oily Skin	TITANIUM DIOXIDE, ZINC OXIDE	Likewise Incorporated	28b8c519-8417-427e-8d4f-94da44a69d9f	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Bass Pro Shops Bass P Sunscreen Broad Spectrum SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	ENGLEWOOD LAB, INC.	c06ecc56-2044-4396-8acd-6d18af9b984c	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	ENGLEWOOD LAB, INC.	f5c7b7ce-b3ed-3e96-e053-2995a90a8ea9	2023-12-12	Warnings	Exact identifier unii: 15FIX9V2JP
Vichy Laboratoires Capital Soleil 60 Mineral Sunscreen Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight	TITANIUM DIOXIDE	LOreal USA Products Inc	4692b146-1abe-48e8-b097-ea9c556962b6	2023-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
Vichy Laboratoires Capital Soleil 60 Mineral Broad Spectrum SPF 60 Water Resistant 80 Minutes Sheer Tint Ultra Lightweight Sunscreen	TITANIUM DIOXIDE	Cosmetique Active Production	acb887bc-7e46-4257-9fe3-a2cade6c4f38	2023-12-11	Warnings	Exact identifier unii: 15FIX9V2JP
Erborian BB creme au Ginseng chocolate SPF 20	OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	ddcd6ea4-e7b1-88df-e053-2a95a90a9923	2023-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
ERBORIAN - BB CREME AU GINSENG CARAMEL SPF20	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	43c81760-6bb6-25fe-e054-00144ff8d46c	2023-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
Erborian CC Dull Correct SPF25	OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDE	LABORATOIRES M&L	cb23ba95-1e83-4523-a35c-3b70c0605dd1	2023-12-09	Warnings	Exact identifier unii: 15FIX9V2JP
Cetaphil Sheer Mineral Sunscreen SPF 30	TITANIUM DIOXIDE, ZINC OXIDE	Galderma Laboratories, L.P.	ac2d5713-9955-477e-a10f-e8a1191b5fdd	2023-12-07	Warnings	Exact identifier unii: 15FIX9V2JP
Folixate	FOLATE, VITAMIN D3	PureTek Corporation	0bb91f61-b61b-c894-e063-6394a90ae51c	2023-12-05	Warnings, Adverse reactions	Exact identifier unii: A9R10K3F2F
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1720cff-a897-68cb-e053-2995a90a30b6	2023-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c12272c3-d4ed-2212-e053-2995a90add37	2023-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c12272c3-d4f0-2212-e053-2995a90add37	2023-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1228ca6-8fb4-5964-e053-2a95a90a30ca	2023-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c12292a8-c98f-eb27-e053-2a95a90a9bbc	2023-12-05	Warnings	Exact identifier unii: 15FIX9V2JP
RECHARGE Regimen for Balancing, Boosting and Defending Healthy-Looking skin	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields	b7401ff8-ca47-4c74-813c-99c5f28c0b6d	2023-12-04	Warnings	Exact identifier unii: 15FIX9V2JP
Perbelle CC SPF43 UVA UVB Broad Spectrum	TITANIUM DIOXIDE	Perbelle Cosmetics Global Ltd.	b5e2724e-9806-5bcc-e053-2a95a90a0508	2023-12-01	Warnings	Exact identifier unii: 15FIX9V2JP
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1228d15-a157-6989-e053-2995a90a44ea	2023-12-01	Warnings	Exact identifier unii: 15FIX9V2JP
Davimet-M	MULTIVITAMIN	PureTek Corporation	0b67e8de-d81e-0fda-e063-6394a90ac229	2023-11-30	Warnings, Adverse reactions	Exact identifier unii: A9R10K3F2F

Reported adverse events (FAERS/openFDA)#

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