FDA.reportPublic FDA data

NDC 68968-3475-08 - 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
68968-3475
Requested NDC
68968-3475-08
Package NDCs from labels
68968-3475-8, 68968-3475-08
Manufacturer
Noven Therapeutics, LLC
Effective date
2024-04-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Estradiol - Noven Therapeutics, LLCNoven Therapeutics, LLC2024-04-05HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68968-3475-8Estradiol8 in 1 CARTONFILM, EXTENDED RELEASE86
68968-3475-8Estradiol1 d in 1 POUCHFILM, EXTENDED RELEASE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68968-3475ESTRADIOL FILM, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]6Current NDC, Legacy NDC, 2 package rows20240522_bf185599-2138-4083-9c52-2b95dce09ae0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68968-3475-1EA - Each68968-3475fb711cdf-332b-4622-baae-dcc1c5e9b91412018-12-13
68968-3475-8EA - Each68968-34758d9403f6-bc5d-4943-a3e7-9938f292329912018-12-13

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 9 · 167 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
EstradiolESTRADIOLPD-Rx Pharmaceuticals, Inc.d0d1c2c8-b175-4250-9343-d7db65b72e8f2025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNuCare Pharmaceuticals,Inc.dd7d2d2a-e76b-7dfe-e053-2995a90a790a2025-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
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
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
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
unii: 4TI98Z838E
EstradiolESTRADIOLDirect_Rx01789bad-4be4-ae22-e063-6294a90af3922025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
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
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
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
EstradiolESTRADIOLA-S Medication Solutionsf7e8dd35-c12f-46be-96f9-bf9a9b6f9a902024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutions41f424ec-9d08-4fda-b21d-41e92da6e1f02024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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