FDA.reportPublic FDA data

NDC 63629-8804-01 - 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
63629-8804
Requested NDC
63629-8804-01
Package NDCs from labels
63629-8804-1, 63629-8804-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-07-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Estradiol - Bryant Ranch PrepackBryant Ranch Prepack2024-07-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8804-1Estradiol18 in 1 CARTONINSERT18103
63629-8804-1Estradiol1 in 1 BLISTER PACKINSERT1103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8804ESTRADIOL INSERT [BRYANT RANCH PREPACK]103Current NDC, Legacy NDC, 2 package rows20240724_d9514497-6b9e-4c13-950b-6b036ff101c1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8804-1EA - Each63629-88042da15761-5521-43b9-b253-204e8fe878fb12021-12-08

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 · 175 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOTTIESTRADIOLBryant Ranch Prepackf419192a-eb95-4087-9fe0-0eea639ef51b2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRACEESTRADIOLA-S Medication Solutionsda52a602-f2a2-4382-be07-30351c58cc4b2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
DOTTIESTRADIOLBryant Ranch Prepack779751dc-243a-4dc2-ae67-3669f196b2052024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol VaginalESTRADIOLBryant Ranch Prepacke7b15ec3-e195-44a6-bdd7-9b6de2b235b82024-07-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutions7f3c96ce-c855-4372-95ba-7759dd82bcca2024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLNuCare Pharmaceuticals, Inc.5423c0da-eb10-20cd-e054-00144ff8d46c2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
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
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepack7eb1b2c3-8ece-47c3-96c0-606f7f5b5a322024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206388
rxcui: 884707
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepackd9514497-6b9e-4c13-950b-6b036ff101c12024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206388
ndc (package): 63629-8804-1
ndc (product): 63629-8804
ndc11 (package): 63629880401
rxcui: 884707
spl id: b18e4c0c-9e05-4cf3-90c4-3b9c5c8b3020
spl set id: d9514497-6b9e-4c13-950b-6b036ff101c1
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
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

Reported adverse events (FAERS/openFDA)#

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