FDA.reportPublic FDA data

NDC 70518-2829-00 - 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
70518-2829-00
Package NDCs from labels
70518-2829-1, 70518-2829-0, 70518-2829-00
Manufacturer
REMEDYREPACK INC.
Effective date
2026-02-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Estradiol Tablets, USPREMEDYREPACK INC.2026-02-13HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2829-02022-02-07C16284748780-1d6a99b39-fa1b-a426-e053-dadaa90af4c2Estradiol Tablets, USP
70518-2829-02022-01-28C16284748780-1d6a99b39-fa1b-a426-e053-dadaa90af4c2Estradiol 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 2 of 9 · 171 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLREMEDYREPACK INC.774ee81b-8e29-46af-ab12-7157f63b443b2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197659
unii: 4TI98Z838E
EstroGelESTRADIOLASCEND Therapeutics US, LLC762ac371-bb8b-47e7-b48f-e80d452c9dd42026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol and Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEIngenus Pharmaceuticals, LLC50c786d6-91bd-4eea-9455-ff2abc08372f2026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLA-S Medication Solutionsafd70875-0a93-40a7-842e-f4359818c2d92026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040275
unii: 4TI98Z838E
EstradiolESTRADIOL GEL 0.1%Xiromed, LLC1a46efe6-21b9-3f0f-90b9-59f279ef51df2026-05-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLEncube Ethicals, Inc.54f108d6-ddd2-4276-8508-2c8e16a65fb22026-05-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol GelESTRADIOLEncube Ethicals, Inc.d4a3606f-83b2-45df-bc77-faebfa796f9a2026-04-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstringESTRADIOLPfizer Laboratories Div Pfizer Inc110b9865-5a07-4d45-b560-e89947f126002026-04-23Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol VaginalESTRADIOLA-S Medication Solutions0137d491-6917-4060-9b32-e0cd7b0badbb2026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLPreferred Pharmaceuticals, Inc.6d129a94-8ecd-40a3-9a95-c5e1ece41ab12026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol VaginalESTRADIOLBryant Ranch Prepack67f581cb-6d77-49fc-b2f3-976e3b57dcbf2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Climara ProESTRADIOL AND LEVONORGESTRELBayer HealthCare Pharmaceuticals Inc.184d3092-7fc6-4375-816b-1ab06bb99cfd2026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ClimaraESTRADIOLBayer HealthCare Pharmaceuticals Inc.1e9702c4-f2d7-4ea8-b6e8-7dca316718642026-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
MenostarESTRADIOLBayer HealthCare Pharmaceuticals Inc.a78708cd-04d4-4221-a4e4-53680bbe29122026-03-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol Transdermal SystemESTRADIOLSandoz Incc714974b-766f-42f2-a846-b0c1f5a605602026-03-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
AngeliqDROSPIRENONE AND ESTRADIOLBayer HealthCare Pharmaceuticals Inc.761834c2-6b61-4583-84c2-f1ca4a97c4f22026-03-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLPadagis Israel Pharmaceuticals Ltd3ac905b3-904c-4285-97ed-e787d006c7dd2026-02-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
DIVIGELESTRADIOLVertical Pharmaceuticals, LLC59e610dc-883e-4f07-9ec6-a5841b0bf9fb2026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Female StimulantACONITICUM ACIDUM, CIS-, APIS VENENUM PURUM, AQUILEGIA VULGARIS, BOVISTA, CYPRIPEDIUM PUBESCENS, ESTRADIOL, FAECALIS (ALKALIGENES), FOLLICULINUM, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEART (SUIS), HYDRASTIS CANADENSIS, HYPOPHYSIS SUIS, KREOSOTUM, LACHESIS MUTUS, LILIUM TIGRINUM, MAGNESIA PHOSPHORICA, MERCURIUS SOLUBILIS, MUTABILE BACILLUS (BACH), OOPHORINUM (SUIS), PETROSELINUM SATIVUM, PINEAL GLAND (SUIS), PLACENTA TOTALIS SUIS, PROGESTERONE, SEPIA, TESTOSTERONE, UTERUS (SUIS)Deseret Biologicals, Inc.0d4b8cbf-8f57-43ca-a904-c69d9056c8652026-02-19WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOL TRANSDERMALAmneal Pharmaceuticals NY LLC9669a0e3-27e2-4f6c-961c-7a67e9f84cc82026-02-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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