FDA.reportPublic FDA data

NDC 70518-3818-2 - 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
70518-3818
Requested NDC
70518-3818-2
Package NDCs from labels
70518-3818-0, 70518-3818-2, 70518-3818-1
Manufacturer
REMEDYREPACK INC.
Effective date
2026-06-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Estradiol Tablets, USPREMEDYREPACK INC.2026-06-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3818-0ESTRADIOL90 in 1 BOTTLE, PLASTICTABLET904
70518-3818-1ESTRADIOL100 in 1 BOXTABLET1004
70518-3818-2ESTRADIOL1 in 1 POUCHTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3818ESTRADIOL TABLET [REMEDYREPACK INC.]2Current NDC, 3 package rows20240402_477cb52e-8ce2-491f-94a0-869ff60bf7ab.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 7 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOTTIESTRADIOLBryant Ranch Prepack99b889a0-6200-4727-97d3-f5a0b7814e1b2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepack9eb88585-4994-474f-bd63-c4e003bf6f202024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197658
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepack7eb1b2c3-8ece-47c3-96c0-606f7f5b5a322024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepackd9514497-6b9e-4c13-950b-6b036ff101c12024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNuCare Pharmaceuticals,Inc.1bbdb10b-9a32-3899-e063-6294a90ab26d2024-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197658
unii: 4TI98Z838E
ESTRADIOL AND NORETHINDRONE ACETATEESTRADIOL AND NORETHINDRONE ACETATENaari Pte. Limitedf70185fe-9fcf-655f-e053-6394a90a20dc2024-06-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLNuCare Pharmaceuticals,Inc.7093dbe4-b096-2ddb-e053-2991aa0a1bb82024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA040275
unii: 4TI98Z838E
MimveyESTRADIOL AND NORETHINDRONE ACETATETeva Pharmaceuticals USA, Inc.b1c5c06b-9ce2-4bf7-9693-e37608055a142024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRACEESTRADIOLAllergan, Inc.dfc41fcd-c5ba-4b25-b647-cf04d3988b3e2024-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLAmneal Pharmaceuticals NY LLCd4259bb8-91f8-4587-8ceb-35d44145aec02024-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
LYLLANAESTRADIOLAmneal Pharmaceuticals LLC09c472c6-a38a-4a3d-b048-6fefd52e2ad32024-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLAmneal Pharmaceuticals NY LLC0500ee9b-bf4a-4432-9afe-20a7d60a6fe52024-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
DOTTIESTRADIOLAmneal Pharmaceuticals LLC53016d30-6b5f-49da-ac16-85ef415a58052024-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLBryant Ranch Prepack0e927450-3f02-4d2f-9235-a255357e8d932024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLBryant Ranch Prepack6a4e82a4-d980-4c04-9e33-9444a292728a2024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLBryant Ranch Prepackeab9a629-b3d4-4faf-bce4-656fe3b46d382024-04-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLANI Pharmaceuticals, Inc.3fe899db-a8cd-4a31-88fb-1129be96b4d92024-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197658
unii: 4TI98Z838E
EstradiolESTRADIOLNoven Therapeutics, LLCbf185599-2138-4083-9c52-2b95dce09ae02024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepack80d6644a-d6f2-48e7-a685-92c4255b19fe2024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197658
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepack414b846a-d6d9-4e8a-9632-12e296fc13c32024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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