FDA.reportPublic FDA data

NDC 0378-7294-85 - ESTRADIOL AND NORETHINDRONE ACETATE

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
0378-7294
Requested NDC
0378-7294-85
Package NDCs from labels
0378-7294-85, 0378-7294-53
Manufacturer
Mylan Pharmaceuticals Inc.
Effective date
2024-04-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ESTRADIOL AND NORETHINDRONE ACETATE - Mylan Pharmaceuticals Inc.Mylan Pharmaceuticals Inc.2024-04-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-7294ESTRADIOL AND NORETHINDRONE ACETATE TABLET [MYLAN PHARMACEUTICALS INC.]9Legacy NDC20250216_6cafe148-bfb8-4c09-a056-b0637c0c3065.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-7294-53EA - Each0378-72943fc85cb2-7931-4f70-8105-0fd53c2da34a12018-08-13
0378-7294-85EA - Each0378-729437ea8218-4635-4242-85a5-d59e21cfdc5612018-08-13

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 5 of 10 · 200 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLMylan Pharmaceuticals Inc.f4efb0bf-b96f-4e20-a0f2-0806ab92b2d42025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
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
unii: 4TI98Z838E
EstradiolESTRADIOLNorthStar Rx LLC0c8a07a4-5762-eaf4-e063-6394a90a54ff2025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
SENSITIVE POCKET SUNSENSITIVE POCKET SUNShantou Oushiya Biotechnology Co., Ltd36ac412f-e31f-6906-e063-6394a90a4a3d2025-06-14WarningsExact identifier
unii: 7SEV7J4R1U
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
LUIZZA 1/20NORETHINDRONE ACETATE AND ETHINYL ESTRADIOLXiromed, LLC88d90f33-1034-4d27-034f-11d9c441c9e72025-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9S44LIC7OJ
EstradiolESTRADIOLA-S Medication Solutions3e84e3e7-4b50-407f-a215-45363b5413842025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLPreferred Pharmaceuticals Inc.72fbd5a8-9c34-4790-84ed-79f5bd3ae0f02025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Prostate LiquescenceSABAL SERRULATA, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS, ESTRADIOL, PROGESTERONE, CONIUM MACULATUM ASTERIAS RUBENS, EUPHORBIUM OFFICINARUM, TRITICUM REPENS, CALCAREA FLUORICA, ARSENICUM ALBUMNutritional Specialties, Inc.0cb4729c-63cd-463b-b1c4-df85118986d02025-04-07WarningsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLBryant Ranch Prepackfad3813c-9495-416b-9789-623d5758b4e32025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLBryant Ranch Prepackcf1ebc1d-8f3c-4468-b565-f0da69986e7c2025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLBryant Ranch Prepackbfc1beb9-1ade-446e-97dd-55b41c2fa8512025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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