NDC 0378-4641-16 - Estradiol

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: 0378-4641
Requested NDC: 0378-4641-16
Package NDCs from labels: 0378-4641-16, 0378-4641-26
Manufacturer: Mylan Pharmaceuticals Inc.
Effective date: 2025-06-17
Current FDA listing: Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
Label	Manufacturer	Effective date	Type
Estradiol - Mylan Pharmaceuticals Inc.	Mylan Pharmaceuticals Inc.	2025-06-17	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0378-4641-16	Estradiol	3.5 d in 1 PATCH	PATCH	3.5	14
0378-4641-16	Estradiol	1 in 1 POUCH	PATCH	1	14
0378-4641-26	Estradiol	8 in 1 CARTON	PATCH	8	14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0378-4641	ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]	13	Current NDC, Legacy NDC, 3 package rows	20241220_d28bec8f-762e-4f05-a20d-96a42970d6a7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0378-4641-16	EA - Each	0378-4641	c16c873b-37ad-4ce8-b16a-869e2ff3b8a3	1	2018-05-09
0378-4641-26	EA - Each	0378-4641	aa9e71af-dae5-41f5-904f-6cbe7bd5db60	1	2015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESTRADIOL	ACTIVE INGREDIENT	4TI98Z838E	ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]	4
ESTRADIOL	ACTIVE MOIETY	4TI98Z838E	ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]	4
DIPROPYLENE GLYCOL	INACTIVE INGREDIENT	E107L85C40	ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]	4
OLEYL ALCOHOL	INACTIVE INGREDIENT	172F2WN8DV	ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]	4
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]	4

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 10 of 12 · 227 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	ANI Pharmaceuticals, Inc.	3fe899db-a8cd-4a31-88fb-1129be96b4d9	2024-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
Estradiol	ESTRADIOL	Noven Therapeutics, LLC	bf185599-2138-4083-9c52-2b95dce09ae0	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1149632 rxcui: 242892 rxcui: 242891 rxcui: 248478 rxcui: 241946 unii: 4TI98Z838E
Estradiol	ESTRADIOL	Bryant Ranch Prepack	80d6644a-d6f2-48e7-a685-92c4255b19fe	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
Estradiol	ESTRADIOL	Bryant Ranch Prepack	414b846a-d6d9-4e8a-9632-12e296fc13c3	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
YUVAFEM	ESTRADIOL	Amneal Pharmaceuticals LLC	30c7f6ba-7a9e-4853-b3e4-e00a46560224	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
Estradiol	ESTRADIOL	Amneal Pharmaceuticals of New York LLC	094830ee-1b1c-4cf7-8a39-427dfd56f9c9	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
Clear Eyes Natural Tears	POLYVINYL ALCOHOL AND POVIDONE	Prestige Brands Holdings, Inc.	efba3eb0-798d-4635-b19b-4970e45b3cc9	2024-04-01	Warnings	Exact identifier unii: FZ989GH94E
Estradiol	ESTRADIOL	Teva Pharmaceuticals USA, Inc.	8cb31c7c-fba8-4201-833d-844ea1a8a4de	2024-04-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
Dr Dale Wellness NU Fem 1 2 3 All In One Topical Homeopathic	DHEA,ADRENAL CORTISOL,GLANDULA SUPRARENALIS SUIS,HUMAN GROWTH HORMONE,IGF-I,IGF-II ,HYPOTHALAMUS,PITUITARY,PLACENTA,LIVER,THYMUS,RNA,DNA,ESTROGENIUM,ESTRADIOLINUM,SANGUINARA CANDENSIS,OOPHORINUM,PROGESTERONIUM,PITITUARINUM,PINEAL,FOLLICULINUM,OVARINUM,CHELADONIUM,SULPHUR,SEPIA,LAGENINE ,TESTOSTERONE,CIMICIFUGA BLACK COHOSH,LILIUM TIGRINUM,GRAPHITES,KALI PHOSPHORICUM ,CAUSTICUM,CALCAREA CARBONICA,PHYTOLACCA,SCROPHULARIA NODOSA	DMD Clinical Naturopathy	7679472c-bc6a-40c1-8e66-adc0b6ca18b4	2024-03-21	Warnings	Exact identifier unii: 4TI98Z838E
estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	684850eb-d889-4370-a0a7-4a5c3113266a	2024-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	db4696da-7820-4b2b-97b4-fb05b1208020	2024-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
Estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	839fe7ae-6835-4d6a-b6b1-ca7f062caa4f	2024-03-15	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 1149632 rxcui: 242892 rxcui: 242891 rxcui: 248478 rxcui: 241946 unii: 4TI98Z838E
REFRESH CLASSIC	POLYVINYL ALCOHOL, POVIDONE	A-S Medication Solutions	3bf6193c-56db-45ad-844c-58eb8c33cba9	2024-03-14	Warnings	Exact identifier unii: FZ989GH94E
High 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, GABA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, OOPHORINUM (SUIS), ORCHITINUM (SUIS), PANCREAS SUIS, SPLEEN (SUIS), APIOLUM,	Deseret Biologicals, Inc.	2fd79cc1-42ed-49f5-b9e1-c48dedd21b1c	2024-03-13	Warnings	Exact identifier unii: 4TI98Z838E
Etyqa	ESTRADIOL AND NORETHINDRONE ACETATE	Aurobindo Pharma Limited	afbc2a33-5eb2-4f01-91e9-07d8050da6ce	2024-03-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
CombiPatch (estradiol/norethindrone acetate transdermal system)	ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM	Noven Therapeutics, LLC	83198ef1-11c4-11e4-9191-0800200c9a66	2024-02-21	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
Estradiol / Norethindrone Acetate	ESTRADIOL AND NORETHINDRONE ACETATE	Breckenridge Pharmaceutical, Inc.	44125b2f-10ac-435c-bdb4-a29bf8450dbf	2024-02-21	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
GOODSENSE ARTIFICIAL TEARS	POLYVINYL ALCOHOL	Proficient Rx LP	f29c792c-6cb2-449f-b97d-6304a58dec2a	2024-02-01	Warnings	Exact identifier unii: FZ989GH94E
GoodSense Artifical Tears	POLYVINYL ALCOHOL, AND POVIDONE	Proficient Rx LP	cd24da78-fd90-4a9c-8e5f-f7fc56ec0fc9	2024-02-01	Warnings	Exact identifier unii: FZ989GH94E
Estradiol	ESTRADIOL	Teva Pharmaceuticals USA, Inc.	c4936878-1643-4e7f-9b0d-e4957935aef2	2024-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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