FDA.reportPublic FDA data

NDC 70518-2829-01 - 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
70518-2829
Requested NDC
70518-2829-01
Package NDCs from labels
70518-2829-1, 70518-2829-0, 70518-2829-01
Manufacturer
REMEDYREPACK INC.
Effective date
2026-10-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Estradiol Tablets, USPREMEDYREPACK INC.2026-10-08HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-02-07Estradiol Tablets, USP
2022-02-07Estradiol Tablets, USP
2022-01-28Estradiol Tablets, USP
2022-01-28Estradiol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2829-0ESTRADIOL100 in 1 BOXTABLET1008
70518-2829-1ESTRADIOL1 in 1 POUCHTABLET18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2829ESTRADIOL TABLET [REMEDYREPACK INC.]6Current NDC, Legacy NDC, 2 package rows20250403_170ec388-d399-4543-8743-208394b38904.zip

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 8 of 9 · 169 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLBryant Ranch Prepack414b846a-d6d9-4e8a-9632-12e296fc13c32024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
YUVAFEMESTRADIOLAmneal Pharmaceuticals LLC30c7f6ba-7a9e-4853-b3e4-e00a465602242024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLAmneal Pharmaceuticals of New York LLC094830ee-1b1c-4cf7-8a39-427dfd56f9c92024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLTeva Pharmaceuticals USA, Inc.8cb31c7c-fba8-4201-833d-844ea1a8a4de2024-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Dr Dale Wellness NU Fem 1 2 3 All In One Topical HomeopathicDHEA,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 NODOSADMD Clinical Naturopathy7679472c-bc6a-40c1-8e66-adc0b6ca18b42024-03-21WarningsExact identifier
unii: 4TI98Z838E
estradiolESTRADIOLZydus Pharmaceuticals USA Inc.684850eb-d889-4370-a0a7-4a5c3113266a2024-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
estradiolESTRADIOLZydus Pharmaceuticals USA Inc.db4696da-7820-4b2b-97b4-fb05b12080202024-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLZydus Pharmaceuticals USA Inc.839fe7ae-6835-4d6a-b6b1-ca7f062caa4f2024-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
High VitalityAGNUS 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-c48dedd21b1c2024-03-13WarningsExact identifier
unii: 4TI98Z838E
EtyqaESTRADIOL AND NORETHINDRONE ACETATEAurobindo Pharma Limitedafbc2a33-5eb2-4f01-91e9-07d8050da6ce2024-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
CombiPatch (estradiol/norethindrone acetate transdermal system)ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEMNoven Therapeutics, LLC83198ef1-11c4-11e4-9191-0800200c9a662024-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol / Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEBreckenridge Pharmaceutical, Inc.44125b2f-10ac-435c-bdb4-a29bf8450dbf2024-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLTeva Pharmaceuticals USA, Inc.c4936878-1643-4e7f-9b0d-e4957935aef22024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197659
unii: 4TI98Z838E
ELESTRINESTRADIOLViatris Specialty LLCeff2dea1-f117-11e3-ac10-0800200c9a662023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
High Vitality TabAGNUS CASTUS, AMBRA GRISEA, ESTRADIOL, L-DOPA, MELATONIN, PETROSELINUM SATIVUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, UBIDECARENONUM, BARYTA CARBONICA, CONIUM MACULATUM, SELENIUM METALLICUM, FOLLICULINUM, TESTOSTERONE, 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 Biologicals4040e55f-9d59-483e-bba1-ec6cd68693752023-12-12WarningsExact identifier
unii: 4TI98Z838E
ActivellaESTRADIOL/NORETHINDRONE ACETATEAmneal Pharmaceuticals LLCd4b0c1dd-aae9-4ca2-958c-71dbe5d0fab02023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Vivelle-DotESTRADIOLSandoz Inc5ccb77f9-d47b-4381-ad5c-5b92524e1c4a2023-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: 4TI98Z838E
Estrogen 4XESTRADIOLNutritional Specialties, Inc.772c2a8a-10e2-49af-8db6-4d5ca64b17192023-07-25WarningsExact identifier
unii: 4TI98Z838E
estradiolESTRADIOLZydus Lifesciences Limited2f2030c2-f72e-4142-9cff-540bc8fbf8a12023-04-21Exact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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