FDA.reportPublic FDA data

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
LabelManufacturerEffective dateType
Estradiol - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2025-06-17HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-4641-16Estradiol3.5 d in 1 PATCHPATCH3.514
0378-4641-16Estradiol1 in 1 POUCHPATCH114
0378-4641-26Estradiol8 in 1 CARTONPATCH814

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-4641ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 3 package rows20241220_d28bec8f-762e-4f05-a20d-96a42970d6a7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4641-16EA - Each0378-4641c16c873b-37ad-4ce8-b16a-869e2ff3b8a312018-05-09
0378-4641-26EA - Each0378-4641aa9e71af-dae5-41f5-904f-6cbe7bd5db6012015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRADIOLACTIVE INGREDIENT4TI98Z838EESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]4
ESTRADIOLACTIVE MOIETY4TI98Z838EESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]4
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]4
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DVESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EESTRADIOL 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 6 of 12 · 227 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
iVIZIA Dry EyePOVIDONEThea Pharma Inc.1ef73cb1-da48-a713-e063-6294a90afa9d2025-10-20WarningsExact identifier
unii: FZ989GH94E
EstradiolESTRADIOLPD-Rx Pharmaceuticals, Inc.f3a77482-f490-f350-e053-2a95a90ad8cb2025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNuCare Pharmaceuticals,Inc.c8ac2e13-58d5-4e70-e053-2995a90aff042025-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Eyes Irritation ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDECARDINAL HEALTH 110, LLC. DBA LEADERbd2608c6-ffdf-352a-e053-2995a90a26a82025-09-12WarningsExact identifier
unii: FZ989GH94E
EstradiolESTRADIOLA-S Medication Solutionse962e36d-5d84-4b39-9bdf-e5f9a264b82a2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutions13f9c41b-417c-45e4-9a59-baf774fca78d2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 241946
unii: 4TI98Z838E
EstradiolESTRADIOLMylan Pharmaceuticals Inc.e7e6da3b-8485-1382-61c9-e9b369018b982025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLMylan Pharmaceuticals Inc.f4efb0bf-b96f-4e20-a0f2-0806ab92b2d42025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1149632
rxcui: 242892
rxcui: 242891
rxcui: 248478
rxcui: 241946
unii: 4TI98Z838E
EstradiolESTRADIOLCoupler LLC37c99e4d-fb0d-0e6e-e063-6394a90a69c82025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLMylan Pharmaceuticals Inc.d28bec8f-762e-4f05-a20d-96a42970d6a72025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201675
ndc (package): 0378-4641-16
ndc (package): 0378-4644-16
ndc (package): 0378-4641-26
ndc (package): 0378-4642-16
ndc (package): 0378-4642-26
ndc (package): 0378-4643-26
ndc (package): 0378-4640-26
ndc (package): 0378-4640-16
ndc (package): 0378-4644-26
ndc (package): 0378-4643-16
ndc (product): 0378-4644
ndc (product): 0378-4641
ndc (product): 0378-4640
ndc (product): 0378-4643
ndc (product): 0378-4642
ndc11 (package): 00378464116
rxcui: 1149632
rxcui: 242892
rxcui: 242891
rxcui: 248478
rxcui: 241946
spl id: e1deb37a-8362-4275-a04c-7abcbb2e9f56
spl set id: d28bec8f-762e-4f05-a20d-96a42970d6a7
unii: 4TI98Z838E
EstradiolESTRADIOLNorthStar Rx LLC0c8a07a4-5762-eaf4-e063-6394a90a54ff2025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
BiEST 5.0 Estrogen CreamESTRIOL,ESTRADIOLSHYNE BRANDSc4d3860f-c211-b18c-e053-2a95a90a44742025-06-01WarningsExact identifier
unii: 4TI98Z838E
BiEST 5.0 Estrogen Cream - 3.6ozESTRIOL,ESTRADIOLSHYNE BRANDS/BIOLabs PRO37d33647-9790-35a8-e063-6294a90a2ad92025-06-01WarningsExact identifier
unii: 4TI98Z838E
3.6oz BiEST 2.5 Estrogen CreamESTRIOL,ESTRADIOL,ESTROGEN CREAMSHYNE BRANDS/BIOLabs PRO37e49c0d-f89f-f88d-e063-6294a90a3f5c2025-06-01WarningsExact identifier
unii: 4TI98Z838E
Balance Plus CreamESTRIOL,ESTRADIOL,PROGESTERONE,DHEASHYNE BRANDS/BIOLabs PRO37e5e4ae-8cb1-19bb-e063-6294a90ac43d2025-06-01WarningsExact identifier
unii: 4TI98Z838E
Estradiol Vaginal CreamESTRADIOLPrasco Laboratoriesc895ac14-5dbd-4201-bf3e-ba7c38a4e9942025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
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
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
EstradiolESTRADIOLA-S Medication Solutions3e84e3e7-4b50-407f-a215-45363b5413842025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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