FDA.reportPublic FDA data

NDC 69238-1295-01 - 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
69238-1295
Requested NDC
69238-1295-01
Package NDCs from labels
69238-1295-1, 69238-1295-7, 69238-1295-01
Manufacturer
Amneal Pharmaceuticals NY LLC
Effective date
2024-05-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Estradiol - Amneal Pharmaceuticals NY LLCAmneal Pharmaceuticals NY LLC2024-05-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1295-1Estradiol1 d in 1 POUCHPATCH, EXTENDED RELEASE111
69238-1295-7Estradiol8 in 1 CARTONPATCH, EXTENDED RELEASE811

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1295ESTRADIOL PATCH, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC]11Current NDC, Legacy NDC, 2 package rows20240607_d4259bb8-91f8-4587-8ceb-35d44145aec0.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 · 166 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
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
application number: ANDA211396
ndc (package): 69238-1294-1
ndc (package): 69238-1295-1
ndc (package): 69238-1293-7
ndc (package): 69238-1293-1
ndc (package): 69238-1296-7
ndc (package): 69238-1447-7
ndc (package): 69238-1447-1
ndc (package): 69238-1296-1
ndc (package): 69238-1294-7
ndc (package): 69238-1295-7
ndc (product): 69238-1296
ndc (product): 69238-1293
ndc (product): 69238-1294
ndc (product): 69238-1447
ndc (product): 69238-1295
ndc11 (package): 69238129501
rxcui: 1149632
rxcui: 242892
rxcui: 242891
rxcui: 248478
rxcui: 241946
spl id: 257bffaf-8bc9-4557-a1e3-bab40bee2fb7
spl set id: d4259bb8-91f8-4587-8ceb-35d44145aec0
unii: 4TI98Z838E
LYLLANAESTRADIOLAmneal Pharmaceuticals LLC09c472c6-a38a-4a3d-b048-6fefd52e2ad32024-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211396
rxcui: 1149632
rxcui: 242892
rxcui: 242891
rxcui: 248478
rxcui: 241946
unii: 4TI98Z838E
EstradiolESTRADIOLAmneal Pharmaceuticals NY LLC0500ee9b-bf4a-4432-9afe-20a7d60a6fe52024-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1149632
rxcui: 242892
rxcui: 242891
rxcui: 248478
rxcui: 241946
unii: 4TI98Z838E
DOTTIESTRADIOLAmneal Pharmaceuticals LLC53016d30-6b5f-49da-ac16-85ef415a58052024-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1149632
rxcui: 242892
rxcui: 242891
rxcui: 248478
rxcui: 241946
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
unii: 4TI98Z838E
EstradiolESTRADIOLNoven Therapeutics, LLCbf185599-2138-4083-9c52-2b95dce09ae02024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 1149632
rxcui: 242892
rxcui: 242891
rxcui: 248478
rxcui: 241946
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepack80d6644a-d6f2-48e7-a685-92c4255b19fe2024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
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

Reported adverse events (FAERS/openFDA)#

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