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 4 of 9 · 175 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Estradiol VaginalESTRADIOLPadagis Israel Pharmaceuticals Ltdf76232ed-b109-43d1-bf2e-d41b6420c37d2025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepackff3bcb07-f6fe-4582-948a-21dbf1e55f552025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOL VAGINAL INSERTSESTRADIOLGlenmark Pharmaceuticals Inc., USA86620f6c-fd02-40df-98d5-3048dcd92c372025-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 884707
unii: 4TI98Z838E
Estradiol VaginalESTRADIOLBryant Ranch Prepackf3806b5d-ebd6-43b4-adfa-a1fe86d806422025-10-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLPD-Rx Pharmaceuticals, Inc.f3a77482-f490-f350-e053-2a95a90ad8cb2025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOL VAGINAL INSERTSESTRADIOLAurobindo Pharma Limited6247e329-e20e-4ea5-9cc1-b593bd4945772025-09-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 884707
EstradiolESTRADIOLNuCare Pharmaceuticals,Inc.c8ac2e13-58d5-4e70-e053-2995a90aff042025-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOL VAGINAL INSERTSESTRADIOLNorthStar Rx LLCad203bfd-28da-45a3-b9c0-7f886eb036342025-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 884707
EstradiolESTRADIOLA-S Medication Solutionse962e36d-5d84-4b39-9bdf-e5f9a264b82a2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutions13f9c41b-417c-45e4-9a59-baf774fca78d2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLMylan Pharmaceuticals Inc.e7e6da3b-8485-1382-61c9-e9b369018b982025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLMylan Pharmaceuticals Inc.f4efb0bf-b96f-4e20-a0f2-0806ab92b2d42025-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLCoupler LLC37c99e4d-fb0d-0e6e-e063-6394a90a69c82025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLMylan Pharmaceuticals Inc.d28bec8f-762e-4f05-a20d-96a42970d6a72025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNorthStar Rx LLC0c8a07a4-5762-eaf4-e063-6394a90a54ff2025-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
BiEST 5.0 Estrogen CreamESTRIOL,ESTRADIOLSHYNE BRANDSc4d3860f-c211-b18c-e053-2a95a90a44742025-06-01WarningsExact identifier
unii: 4TI98Z838E
BiEST 5.0 Estrogen Cream - 3.6ozESTRIOL,ESTRADIOLSHYNE BRANDS/BIOLabs PRO37d33647-9790-35a8-e063-6294a90a2ad92025-06-01WarningsExact identifier
unii: 4TI98Z838E
3.6oz BiEST 2.5 Estrogen CreamESTRIOL,ESTRADIOL,ESTROGEN CREAMSHYNE BRANDS/BIOLabs PRO37e49c0d-f89f-f88d-e063-6294a90a3f5c2025-06-01WarningsExact identifier
unii: 4TI98Z838E
Balance Plus CreamESTRIOL,ESTRADIOL,PROGESTERONE,DHEASHYNE BRANDS/BIOLabs PRO37e5e4ae-8cb1-19bb-e063-6294a90ac43d2025-06-01WarningsExact identifier
unii: 4TI98Z838E
Estradiol Vaginal CreamESTRADIOLPrasco Laboratoriesc895ac14-5dbd-4201-bf3e-ba7c38a4e9942025-05-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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