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 5 of 9 · 169 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
application number: ANDA040275
unii: 4TI98Z838E
ESTRADIOLESTRADIOLBryant Ranch Prepackcf1ebc1d-8f3c-4468-b565-f0da69986e7c2025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040275
unii: 4TI98Z838E
ESTRADIOLESTRADIOLBryant Ranch Prepackbfc1beb9-1ade-446e-97dd-55b41c2fa8512025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040275
rxcui: 197659
unii: 4TI98Z838E
EstradiolESTRADIOLPD-Rx Pharmaceuticals, Inc.d0d1c2c8-b175-4250-9343-d7db65b72e8f2025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197659
unii: 4TI98Z838E
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
EstradiolESTRADIOLNuCare Pharmaceuticals,Inc.dd7d2d2a-e76b-7dfe-e053-2995a90a790a2025-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197659
unii: 4TI98Z838E
EstradiolESTRADIOLPD-Rx Pharmaceuticals, Inc.aa396e57-0a93-49cc-82e5-cd35c987bb0b2025-02-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLA-S Medication Solutions8788ddd1-36a6-416a-b527-75eb41de28082025-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040275
rxcui: 197659
unii: 4TI98Z838E
Estradiol VaginalESTRADIOLNuCare Pharmaceuticals, Inc.2e5a4d78-6683-4fb8-e063-6294a90a49e72025-02-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLAsclemed USA, Inc.487ce40e-1f13-4497-994a-c5d91b87b6cc2025-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040275
rxcui: 197659
unii: 4TI98Z838E
VagifemESTRADIOLNovo Nordiske5ad3cf6-dd96-4e64-af21-c1eee38d0b882025-02-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLDirect_Rx032135ee-7bc9-5cdf-e063-6394a90ad9a22025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040275
rxcui: 197659
unii: 4TI98Z838E
EstradiolESTRADIOLDirect_Rx01789bad-4be4-ae22-e063-6294a90af3922025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040275
unii: 4TI98Z838E
EstradiolESTRADIOLPharmPak, Inc.20b50139-4e13-4f0c-aaf5-ecb83911d9e62025-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
LOPREEZAESTRADIOL/NORETHINDRONE ACETATEAmneal Pharmaceuticals NY LLC966ac064-9eb7-4d15-b271-a7880ed1e79a2025-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLA-S Medication Solutions376beb31-5fed-4aae-a16f-71a7d243d5eb2025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040275
unii: 4TI98Z838E
Estradiol VaginalESTRADIOLA-S Medication Solutionse5dbfeff-188f-4991-b2b7-f5f03987f7fb2025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLPURACAP LABORATORIES, LLC97ace322-341a-4d52-8c63-17265ed9aa8d2025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040275
rxcui: 197659
unii: 4TI98Z838E
Strength FALPHA-KETOGLUTARICUM ACIDUM, ISOLEUCINE, L-ARGININE, L CARNITINE, L-LEUCINE, L-ORNITHINE, L-VALINE, ESTRADIOL, FOLLICULINUM, PROGESTERONE, TESTOSTERONE, OOPHORINUM (SUIS)BioActive Nutritional, Inc.a4f3a8e7-0a28-4aa0-ba0c-201807d62c962025-01-03WarningsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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