FDA.reportPublic FDA data

NDC 70710-1191-1 - 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
70710-1191
Requested NDC
70710-1191-1
Package NDCs from labels
70710-1191-1, 70710-1191-8
Manufacturer
Zydus Pharmaceuticals USA Inc. | ZYDUS NOVELTECH INC, USA | Zydus Lifesciences Limited
Effective date
2024-03-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Estradiol - Zydus Pharmaceuticals USA Inc. | ZYDUS NOVELTECH INC, USA | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | ZYDUS NOVELTECH INC, USA | Zydus Lifesciences Limited2024-03-15HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70710-1191-1Estradiol1 in 1 POUCHPATCH, EXTENDED RELEASE14
70710-1191-1Estradiol3.5 d in 1 PATCHPATCH, EXTENDED RELEASE3.54
70710-1191-8Estradiol8 in 1 BOXPATCH, EXTENDED RELEASE84

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1191ESTRADIOL PATCH, EXTENDED RELEASE [ZYDUS PHARMACEUTICALS USA INC.]4Current NDC, 3 package rows20240319_839fe7ae-6835-4d6a-b6b1-ca7f062caa4f.zip

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 33 of 45 · 882 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
VAXR HCTHUJA OCCIDENTALIS, MEZEREUM, SILICEA, CALCAREA CARBONICA, MORBILLINUM, PAROTIDINUM, PERTUSSINUM, RUBELLA NOSODE, TETANUS TOXIN, CARCINOSIN, ANTIMONIUM CRUDUM, LEDUM PALUSTRE, THIMEROSAL, POLIOMYELITIS NOSODEDeseret Biologicals, Inc.fdf8d21a-2ae1-4842-abf3-7378419959392024-04-03WarningsExact identifier
unii: ETJ7Z6XBU4
YUVAFEMESTRADIOLAmneal Pharmaceuticals LLC30c7f6ba-7a9e-4853-b3e4-e00a465602242024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLAmneal Pharmaceuticals of New York LLC094830ee-1b1c-4cf7-8a39-427dfd56f9c92024-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Clear Eyes Natural TearsPOLYVINYL ALCOHOL AND POVIDONEPrestige Brands Holdings, Inc.efba3eb0-798d-4635-b19b-4970e45b3cc92024-04-01WarningsExact identifier
unii: FZ989GH94E
EstradiolESTRADIOLTeva Pharmaceuticals USA, Inc.8cb31c7c-fba8-4201-833d-844ea1a8a4de2024-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Headache HPBELLADONNA, BRYONIA, GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NATRUM MURIATICUMEnergique, Inc.5dca8670-c931-47e3-af89-b5f09f5f4e022024-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
PNEUMOPLEXPLANTAGO MAJOR, ARSENICUM ALBUM, LUNG (BOVINE), SYMPHYTUM OFFICINALE, SILICEA, PHELLANDRIUM AQUATICUM, PHOSPHORUS, SULPHURBioActive Nutritional, Inc.d839aea1-7725-40c1-b000-228843f75b932024-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
LymphastatBAPTISIA TINCTORIA, ECHINACEA (ANGUSTIFOLIA), LOBELIA INFLATA, LOMATIUM DISSECTUM, HYDRASTIS CANADENSIS, LUNG (SUIS), PHYTOLACCA DECANDRA, SYMPHYTUM OFFICINALE, ACONITUM NAPELLUS, ARSENICUM ALBUM, BELLADONNA, BRYONIA (ALBA), CAUSTICUM, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, NATRUM SULPHURICUM, PHOSPHORUS, PULSATILLA (PRATENSIS), RHUS TOX, SILICEA, SULPHUR, PYROGENIUMEnergique, Inc.95406534-526e-4bca-b73d-1030623549a32024-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
EnvirotoxTRITICUM AESTIVUM, BERBERIS VULGARIS, LAPPA MAJOR, RHAMNUS PURSHIANA, SENNS (CASSIA ANGUSTIFOLIA), PHYTOLACCA DECANDRA, GLYCYRRHIZA GLABRA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, ACETONUM ACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM.BioActive Nutritional, Inc.2b5cfdba-cf4d-4eb0-8c60-20eac69226632024-03-26WarningsExact identifier
unii: 6DC9Q167V3
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
Snore-SootheECHINACEA, BRYONIA, CAMPHORA, CISTUS CANADENSIS, DROSERA, HEPAR SULPHURIS CALCAREUM, HYDRASTIS CANADENSIS, IGNATIA AMARA, IODIUM, KALI BICHROMICUM, KALI IODATUM, PHOSPHORUS, PULSATILLA, SABADILLA, SILICEA, STICTA PULMONARIA, SULPHUR, TEUCRIUM MARUM, VERBASCUM THAPSUS, ARSENICUM ALBUM, BELLADONNA, HISTAMINUM HYDROCHLORICUM, LAC CANINUM, NUX VOMICANewton Laboratories, Inc.140a0bcf-82b3-c430-e063-6294a90ad38f2024-03-19WarningsExact identifier
unii: ETJ7Z6XBU4
EstradiolESTRADIOLZydus Pharmaceuticals USA Inc.839fe7ae-6835-4d6a-b6b1-ca7f062caa4f2024-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA206241
ndc (package): 70710-1193-8
ndc (package): 70710-1192-1
ndc (package): 70710-1193-1
ndc (package): 70710-1192-8
ndc (package): 70710-1191-1
ndc (package): 70710-1194-8
ndc (package): 70710-1191-8
ndc (package): 70710-1195-8
ndc (package): 70710-1194-1
ndc (package): 70710-1195-1
ndc (product): 70710-1191
ndc (product): 70710-1195
ndc (product): 70710-1194
ndc (product): 70710-1193
ndc (product): 70710-1192
ndc11 (package): 70710119101
rxcui: 1149632
rxcui: 242892
rxcui: 242891
rxcui: 248478
rxcui: 241946
spl id: 51a2adf6-a381-42cb-bf3e-8c83a7cfe738
spl set id: 839fe7ae-6835-4d6a-b6b1-ca7f062caa4f
unii: 4TI98Z838E
DizzyCEREBELLUM (SUIS), BRYONIA (ALBA), PETROLEUM, TABACUM, AMBRA GRISEA, CYCLAMEN EUROPAEUM, NATRUM SALICYLICUM, ARGENTUM NITRICUM, ASARUM CANADENSE, CALCAREA SULPHURICA, CARBONEUM SULPHURATUM, CHININUM SULPHURICUM, COCCULUS INDICUS, CONIUM MACULATUM, DIGITALIS PURPUREA, GELSEMIUM SEMPERVIRENS, PHOSPHORUS, PIPER METHYSTICUM, SILICEA, THERIDIONDeseret Biologicals, Inc.fdf934f8-7b12-4076-b8fb-00c0959406972024-03-15WarningsExact identifier
unii: ETJ7Z6XBU4
REFRESH CLASSICPOLYVINYL ALCOHOL, POVIDONEA-S Medication Solutions3bf6193c-56db-45ad-844c-58eb8c33cba92024-03-14WarningsExact identifier
unii: FZ989GH94E
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
VerARTEMISIA VULGARIS, ASCARIS LUMBRICOIDES, BRUGIA MALAYI, CALCAREA CARBONICA, CINA, CRYPTOSPORIDIUM PARVUM, ENTEROBIUS VERMICULARIS, FILIX MAS, GIARDIA LAMBLIA, GRAPHITES, IODIUM, MERCURIUS CORROSIVUS, QUASSIA (AMARA), SABADILLA, SILICEA, SPIGELIA ANTHELMIA, TAENIA SAGINATA, TAENIA SOLIUM, TEUCRIUM MARUM, THYMUS SERPYLLUM, TRICHINELLA SPIRALIS, TRICHOMONAS VAGINALISDeseret Biologicals, Inc.b47bdd57-14cd-46e9-a34e-0d8a7c21bda22024-03-12WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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