NDC 50419-453-01 - Climara

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: 50419-453
Requested NDC: 50419-453-01
Package NDCs from labels: 50419-453-01, 50419-453-04
Manufacturer: Bayer HealthCare Pharmaceuticals Inc. | Kindeva Drug Delivery L.P. | Sixarp, LLC
Effective date: 2026-03-26
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Climara - Bayer HealthCare Pharmaceuticals Inc. \| Kindeva Drug Delivery L.P. \| Sixarp, LLC	Bayer HealthCare Pharmaceuticals Inc. \| Kindeva Drug Delivery L.P. \| Sixarp, LLC	2026-03-26	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50419-453-01	Climara	7 d in 1 PATCH	PATCH	7		25
50419-453-04	Climara	4 in 1 CARTON	PATCH	4		25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50419-453	CLIMARA (ESTRADIOL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.]	18	Current NDC, Legacy NDC, 2 package rows	20241109_1e9702c4-f2d7-4ea8-b6e8-7dca31671864.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50419-453-04	EA - Each	50419-453	5ec84e84-f074-42f8-9d79-25c769067601	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
ESTRADIOL	ACTIVE INGREDIENT	4TI98Z838E	CLIMARA (ESTRADIOL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8
ESTRADIOL	ACTIVE MOIETY	4TI98Z838E	CLIMARA (ESTRADIOL) PATCH [BAYER HEALTHCARE PHARMACEUTICALS INC.]	8

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 9 of 9 · 167 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	Zydus Lifesciences Limited	b79fd5ea-962f-491c-b670-40efe42ccf79	2022-12-07		Exact identifier unii: 4TI98Z838E
ESTRADIOL	ESTRADIOL	Asclemed USA, Inc.	229b4ec5-d3c8-4406-9fc5-8f633c6447b8	2022-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
Estradiol	ESTRADIOL	PharmPak, Inc.	8f8c5a0b-4d7b-a5cb-e053-2995a90a494e	2022-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
HGH Vitality	AGNUS CASTUS, AMBRA GRISEA, PETROSELINUM SATIVUM, ESTRADIOL, L-DOPA, MELATONIN, TESTOSTERONE, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, UBIDECARENONUM, BARYTA CARBONICA, CONIUM MACULATUM, SELENIUM METALLICUM, FOLLICULINUM, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, OOPHORINUM (SUIS), ORCHITINUM (SUIS), PANCREAS SUIS, SPLEEN (SUIS), HUMAN GROWTH HORMONE,	Deseret Biologicals, Inc.	8b6077c2-ecab-441a-8196-fcf736643fc6	2022-03-28	Warnings	Exact identifier unii: 4TI98Z838E
GUNA-PMS	ARSENIC TRIOXIDE - ESTRADIOL - GOLDENSEAL - LACHESIS MUTA VENOM - MAGNESIUM PHOSPHATE - MATRICARIA RECUTITA - MELATONIN - PROGESTERONE - STRYCHNOS NUX-VOMICA SEED - SULFUR - SUS SCROFA OVARY - SUS SCROFA PITUITARY GLAND -	Guna spa	86f341b1-a8f7-4833-a1be-e51610b05bcd	2018-12-21	Warnings	Exact identifier unii: 4TI98Z838E
Lopreeza	ESTRADIOL/NORETHINDRONE ACETATE	Amneal Pharmaceuticals NY LLC	bf0e39cb-95e7-4831-92d2-0b3f071aeaae	2017-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
Estrogen and Progesterone	AGNUS CASTUS, ANGELICA SINENSIS, APIS MELLIFICA, ARNICA MONTANA, CIMICIFUGA RACEMOSA, ESTRADIOL, ESTRIOL, FOLLICULINUM, GALIUM APARINE, GLYCYRRHIZA GLABRA, KOREAN GINSENG, OOPHORINUM (SUIS), PROGESTERONE, SEPIA, THUJA OCCIDENTALIS, VISCUM ALBUM	ProBLEN	71fec93b-43b7-4ebb-ab5c-5f544d8e6cbf	2017-01-12	Warnings	Exact identifier unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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