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 5 of 9 · 175 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Female StimulantLILIUM TIGRINUM, BOVISTA, CYPRIPEDIUM PUBESCENS, HYDRASTIS CANADENSIS, PETROSELINUM SATIVUM, AQUILEGIA VULGARIS, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEART (SUIS), KREOSOTUM, OOPHORINUM (SUIS), UTERUS (SUIS), FOLLICULINUM, LACHESIS MUTUS, MAGNESIA PHOSPHORICA, MERCURIUS SOLUBILIS, SEPIA, PINEAL GLAND (SUIS), HYPOPHYSIS SUIS, ACONITICUM ACIDUM CIS-, APIS VENENUM PURUM, ESTRADIOL, PROGESTERONE, TESTOSTERONE, PLACENTA TOTALIS SUIS, FAECALIS (ALKALIGENES), MUTABILE BACILLUS (BACH)Deseret Biologicals, Inc.18d072ec-93e1-4e20-82db-98e80b81c3632025-05-27WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLAmerican Health Packaging265a1ee1-f314-4324-a2e1-0120a9a00a202025-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLPreferred Pharmaceuticals Inc.9956a196-fefd-4766-a225-e154fbd3aeff2025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutions3e84e3e7-4b50-407f-a215-45363b5413842025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLPreferred Pharmaceuticals Inc.72fbd5a8-9c34-4790-84ed-79f5bd3ae0f02025-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Prostate LiquescenceSABAL SERRULATA, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, THUJA OCCIDENTALIS, ESTRADIOL, PROGESTERONE, CONIUM MACULATUM ASTERIAS RUBENS, EUPHORBIUM OFFICINARUM, TRITICUM REPENS, CALCAREA FLUORICA, ARSENICUM ALBUMNutritional Specialties, Inc.0cb4729c-63cd-463b-b1c4-df85118986d02025-04-07WarningsExact identifier
unii: 4TI98Z838E
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
Vista Gonio Eye LubricantHYPROMELLOSE OPHTHALMIC SOLUTIONRed Wedding LLC00da365d-2988-9c9e-e063-6294a90a89312025-03-25WarningsExact identifier
unii: B1QE5P712K
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
rxcui: 884707
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

Reported adverse events (FAERS/openFDA)#

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