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 8 of 9 · 175 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
rxcui: 884707
unii: 4TI98Z838E
EstradiolESTRADIOLAmneal Pharmaceuticals of New York LLC094830ee-1b1c-4cf7-8a39-427dfd56f9c92024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 884707
unii: 4TI98Z838E
EstradiolESTRADIOLTeva Pharmaceuticals USA, Inc.8cb31c7c-fba8-4201-833d-844ea1a8a4de2024-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206388
ndc (product): 0093-3223
rxcui: 884707
spl id: c9460fad-4385-488b-8253-b7a4a44683d0
spl set id: 8cb31c7c-fba8-4201-833d-844ea1a8a4de
unii: 4TI98Z838E
Pure Cornstarch BabyCORN STARCHWalgreen Companyd0e9bd13-b568-4f7e-b036-8d23e71ad8bf2024-03-25WarningsExact identifier
unii: O8232NY3SJ
Dr Dale Wellness NU Fem 1 2 3 All In One Topical HomeopathicDHEA,ADRENAL CORTISOL,GLANDULA SUPRARENALIS SUIS,HUMAN GROWTH HORMONE,IGF-I,IGF-II ,HYPOTHALAMUS,PITUITARY,PLACENTA,LIVER,THYMUS,RNA,DNA,ESTROGENIUM,ESTRADIOLINUM,SANGUINARA CANDENSIS,OOPHORINUM,PROGESTERONIUM,PITITUARINUM,PINEAL,FOLLICULINUM,OVARINUM,CHELADONIUM,SULPHUR,SEPIA,LAGENINE ,TESTOSTERONE,CIMICIFUGA BLACK COHOSH,LILIUM TIGRINUM,GRAPHITES,KALI PHOSPHORICUM ,CAUSTICUM,CALCAREA CARBONICA,PHYTOLACCA,SCROPHULARIA NODOSADMD Clinical Naturopathy7679472c-bc6a-40c1-8e66-adc0b6ca18b42024-03-21WarningsExact identifier
unii: 4TI98Z838E
estradiolESTRADIOLZydus Pharmaceuticals USA Inc.684850eb-d889-4370-a0a7-4a5c3113266a2024-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
estradiolESTRADIOLZydus Pharmaceuticals USA Inc.db4696da-7820-4b2b-97b4-fb05b12080202024-03-20Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLZydus Pharmaceuticals USA Inc.839fe7ae-6835-4d6a-b6b1-ca7f062caa4f2024-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
High 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, GABA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, HYPOTHALAMUS SUIS, LYMPH NODE (SUIS), MEDULLA OSSIS SUIS, OOPHORINUM (SUIS), ORCHITINUM (SUIS), PANCREAS SUIS, SPLEEN (SUIS), APIOLUM,Deseret Biologicals, Inc.2fd79cc1-42ed-49f5-b9e1-c48dedd21b1c2024-03-13WarningsExact identifier
unii: 4TI98Z838E
EtyqaESTRADIOL AND NORETHINDRONE ACETATEAurobindo Pharma Limitedafbc2a33-5eb2-4f01-91e9-07d8050da6ce2024-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
CombiPatch (estradiol/norethindrone acetate transdermal system)ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEMNoven Therapeutics, LLC83198ef1-11c4-11e4-9191-0800200c9a662024-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol / Norethindrone AcetateESTRADIOL AND NORETHINDRONE ACETATEBreckenridge Pharmaceutical, Inc.44125b2f-10ac-435c-bdb4-a29bf8450dbf2024-02-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLTeva Pharmaceuticals USA, Inc.c4936878-1643-4e7f-9b0d-e4957935aef22024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ELESTRINESTRADIOLViatris Specialty LLCeff2dea1-f117-11e3-ac10-0800200c9a662023-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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