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 9 of 9 · 175 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
High Vitality TabAGNUS CASTUS, AMBRA GRISEA, ESTRADIOL, L-DOPA, MELATONIN, PETROSELINUM SATIVUM, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, UBIDECARENONUM, BARYTA CARBONICA, CONIUM MACULATUM, SELENIUM METALLICUM, FOLLICULINUM, TESTOSTERONE, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, OOPHORINUM (SUIS), ORCHITINUM (SUIS), PANCREAS SUIS, SPLEEN (SUIS), HUMAN GROWTH HORMONE,Deseret Biologicals4040e55f-9d59-483e-bba1-ec6cd68693752023-12-12WarningsExact identifier
unii: 4TI98Z838E
ActivellaESTRADIOL/NORETHINDRONE ACETATEAmneal Pharmaceuticals LLCd4b0c1dd-aae9-4ca2-958c-71dbe5d0fab02023-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Vivelle-DotESTRADIOLSandoz Inc5ccb77f9-d47b-4381-ad5c-5b92524e1c4a2023-11-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: 4TI98Z838E
Estrogen 4XESTRADIOLNutritional Specialties, Inc.772c2a8a-10e2-49af-8db6-4d5ca64b17192023-07-25WarningsExact identifier
unii: 4TI98Z838E
estradiolESTRADIOLZydus Lifesciences Limited2f2030c2-f72e-4142-9cff-540bc8fbf8a12023-04-21Exact identifier
unii: 4TI98Z838E
estradiolESTRADIOLZydus Lifesciences Limited8b672c79-0896-4d6e-b225-299e89068ad72023-04-21Exact identifier
unii: 4TI98Z838E
Young AgainAGNUS CASTUS, AMBRA GRISEA, PETROSELINUM SATIVUM, ESTRADIOL, L-DOPA, MELATONIN, TESTOSTERONE, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, UBIDECARENONUM, BARYTA CARBONICA, CONIUM MACULATUM, SELENIUM METALLICUM, FOLLICULINUM, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, OOPHORINUM (SUIS), ORCHITINUM (SUIS), PANCREAS SUIS, SPLEEN (SUIS), HUMAN GROWTH HORMONE,Dr. Donna Restivo DCb29089e4-83e1-49ab-b5dd-2ef7fbb008e32023-01-10WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLZydus Lifesciences Limitedb79fd5ea-962f-491c-b670-40efe42ccf792022-12-07Exact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLAsclemed USA, Inc.229b4ec5-d3c8-4406-9fc5-8f633c6447b82022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLPharmPak, Inc.8f8c5a0b-4d7b-a5cb-e053-2995a90a494e2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
HGH VitalityAGNUS CASTUS, AMBRA GRISEA, PETROSELINUM SATIVUM, ESTRADIOL, L-DOPA, MELATONIN, TESTOSTERONE, ADENOSINUM TRIPHOSPHORICUM DINATRUM, ALPHA-LIPOICUM ACIDUM, NADIDUM, PANTOTHENIC ACID, SARCOLACTICUM ACIDUM, UBIDECARENONUM, BARYTA CARBONICA, CONIUM MACULATUM, SELENIUM METALLICUM, FOLLICULINUM, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, OOPHORINUM (SUIS), ORCHITINUM (SUIS), PANCREAS SUIS, SPLEEN (SUIS), HUMAN GROWTH HORMONE,Deseret Biologicals, Inc.8b6077c2-ecab-441a-8196-fcf736643fc62022-03-28WarningsExact identifier
unii: 4TI98Z838E
GUNA-PMSARSENIC TRIOXIDE - ESTRADIOL - GOLDENSEAL - LACHESIS MUTA VENOM - MAGNESIUM PHOSPHATE - MATRICARIA RECUTITA - MELATONIN - PROGESTERONE - STRYCHNOS NUX-VOMICA SEED - SULFUR - SUS SCROFA OVARY - SUS SCROFA PITUITARY GLAND -Guna spa86f341b1-a8f7-4833-a1be-e51610b05bcd2018-12-21WarningsExact identifier
unii: 4TI98Z838E
LopreezaESTRADIOL/NORETHINDRONE ACETATEAmneal Pharmaceuticals NY LLCbf0e39cb-95e7-4831-92d2-0b3f071aeaae2017-11-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estrogen and ProgesteroneAGNUS CASTUS, ANGELICA SINENSIS, APIS MELLIFICA, ARNICA MONTANA, CIMICIFUGA RACEMOSA, ESTRADIOL, ESTRIOL, FOLLICULINUM, GALIUM APARINE, GLYCYRRHIZA GLABRA, KOREAN GINSENG, OOPHORINUM (SUIS), PROGESTERONE, SEPIA, THUJA OCCIDENTALIS, VISCUM ALBUMProBLEN71fec93b-43b7-4ebb-ab5c-5f544d8e6cbf2017-01-12WarningsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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