FDA.reportPublic FDA data

NDC 51285-063-89 - Prefest

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
51285-063
Requested NDC
51285-063-89
Package NDCs from labels
51285-063-89, 51285-063-90
Manufacturer
Teva Women's Health LLC
Effective date
2024-06-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Prefest - Teva Women's Health LLCTeva Women's Health LLC2024-06-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51285-063-90EA - Each51285-063ce371f4b-97f8-4f68-b26a-a570c0d9c69812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRADIOLACTIVE INGREDIENT4TI98Z838EPREFEST (ESTRADIOL/NORGESTIMATE) KIT [TEVA WOMEN'S HEALTH, INC.]5
NORGESTIMATEACTIVE INGREDIENTC291HFX4DYPREFEST (ESTRADIOL/NORGESTIMATE) KIT [TEVA WOMEN'S HEALTH, INC.]5
ESTRADIOLACTIVE MOIETY4TI98Z838EPREFEST (ESTRADIOL/NORGESTIMATE) KIT [TEVA WOMEN'S HEALTH, INC.]5
NORGESTIMATEACTIVE MOIETYC291HFX4DYPREFEST (ESTRADIOL/NORGESTIMATE) KIT [TEVA WOMEN'S HEALTH, INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKPREFEST (ESTRADIOL/NORGESTIMATE) KIT [TEVA WOMEN'S HEALTH, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREFEST (ESTRADIOL/NORGESTIMATE) KIT [TEVA WOMEN'S HEALTH, INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PREFEST (ESTRADIOL/NORGESTIMATE) KIT [TEVA WOMEN'S HEALTH, INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8PREFEST (ESTRADIOL/NORGESTIMATE) KIT [TEVA WOMEN'S HEALTH, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREFEST (ESTRADIOL/NORGESTIMATE) KIT [TEVA WOMEN'S HEALTH, INC.]5

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 6 of 9 · 169 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLA-S Medication Solutions41f424ec-9d08-4fda-b21d-41e92da6e1f02024-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EvamistESTRADIOLPadagis US LLC9a0aa631-133d-406b-9d32-8a1a99af4e502024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLANI Pharmaceuticals, Inc.3518120e-cc44-4d70-8a20-0ef2dce9a3c62024-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstrogensESTRADIOL, FOLLICULINUM, OOPHORINUM (SUIS)Energique, Inc.e0686139-824f-42bc-8610-bb003d7edc3f2024-10-24WarningsExact identifier
unii: 4TI98Z838E
ESTROGEN PHENOLICESTRADIOL,Energique, Inc.716cd86c-af47-45a6-b710-fed421e78fb52024-10-24WarningsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLProficient Rx LP7e570b07-2a9e-49bf-b224-1e34f6eda3ab2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLNuCare Pharmaceuticals,Inc.230c2eda-b0f1-d9ec-e063-6394a90a603c2024-09-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Female LiquescenceDIOSCOREA VILLOSA, GLYCYRRHIZA GLABRA, HAMAMELIS VIRGINIANA, RUBUS IDAEUS, VIBURNUM OPULUS, CAULOPHYLLUM THALICTROIDES, ESTRADIOL, OOPHORINUM (SUIS), PROGESTERONE, UTERUS (SUIS), HUMAN GROWTH HORMONE (HGH), IGNATIA AMARANutritional Specialties, Inc.afc50cd7-61e5-45a6-9195-46a98d3f38e12024-09-25WarningsExact identifier
unii: 4TI98Z838E
ABIGALE LOESTRADIOL AND NORETHINDRONE ACETATEXiromed LLCdf013d36-de10-0607-7e12-95ed43bf7ee92024-09-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLBryant Ranch Prepack5e9bd73f-67db-44f9-a5ee-409eed765cd22024-09-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Immune ForteDEHYDROEPIANDROSTERONE (DHEA), ESTRADIOL, HYPOPHYSIS SUIS, PREGNENOLONE, PROGESTERONE, SPLEEN (BOVINE), TESTOSTERONE, THYMUS (SUIS), THYROIDINUM (SUIS)BioActive Nutritional, Inc.9c355245-260a-464b-abcf-95416b49caa32024-08-29WarningsExact identifier
unii: 4TI98Z838E
Multi-PhenolicMANNOSE, 5-HYDROXYTRYPTOPHAN, ACETALDEHYDE, ACETYLCHOLINE CHLORIDE, ASCORBICUM ACIDUM, ASPARTAME, BUTYLATED HYDROXYTOLUENE, CAFFEIC ACID, CANDIDA ALBICANS, CINNAMIC ACID, CONIFERYL ALCOHOL, COUMARINUM, DOPAMINE HYDROCHLORIDE, ESTRADIOL, GABA (GAMMA-AMINOBUTYRIC ACID), GALLICUM ACIDUM, HISTAMINUM HYDROCHLORICUM, HYDROCORTISONE, INDOLUM, L-DOPA, L-PHENYLALANINE, MELATONIN, MENADIONE, NOREPINEPHRINE (BITARTRATE), PETROSELINUM CRISPUM, PHENYL ISOTHIOCYANATE, PIPERINE, PROGESTERONE, PYRROLE, QUERCETIN,Energique, Inc.492b412a-01cc-48f2-bcdc-6fffcc6519632024-08-23WarningsExact identifier
unii: 4TI98Z838E
DOTTIESTRADIOLBryant Ranch Prepack75fc6d3a-49b6-47ad-b704-410692010d3a2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
DOTTIESTRADIOLBryant Ranch Prepackb119df4a-c514-4804-b1a8-b09c6058e80d2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
DOTTIESTRADIOLBryant Ranch Prepackf419192a-eb95-4087-9fe0-0eea639ef51b2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRACEESTRADIOLA-S Medication Solutionsda52a602-f2a2-4382-be07-30351c58cc4b2024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
DOTTIESTRADIOLBryant Ranch Prepack779751dc-243a-4dc2-ae67-3669f196b2052024-08-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
Estradiol VaginalESTRADIOLBryant Ranch Prepacke7b15ec3-e195-44a6-bdd7-9b6de2b235b82024-07-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
EstradiolESTRADIOLA-S Medication Solutions7f3c96ce-c855-4372-95ba-7759dd82bcca2024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E
ESTRADIOLESTRADIOLNuCare Pharmaceuticals, Inc.5423c0da-eb10-20cd-e054-00144ff8d46c2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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