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
Label	Manufacturer	Effective date	Type
Prefest - Teva Women's Health LLC	Teva Women's Health LLC	2024-06-26	HUMAN PRESCRIPTION DRUG LABEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51285-063-90	EA - Each	51285-063	ce371f4b-97f8-4f68-b26a-a570c0d9c698	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESTRADIOL	ACTIVE INGREDIENT	4TI98Z838E	PREFEST (ESTRADIOL/NORGESTIMATE) KIT [TEVA WOMEN'S HEALTH, INC.]	5
NORGESTIMATE	ACTIVE INGREDIENT	C291HFX4DY	PREFEST (ESTRADIOL/NORGESTIMATE) KIT [TEVA WOMEN'S HEALTH, INC.]	5
ESTRADIOL	ACTIVE MOIETY	4TI98Z838E	PREFEST (ESTRADIOL/NORGESTIMATE) KIT [TEVA WOMEN'S HEALTH, INC.]	5
NORGESTIMATE	ACTIVE MOIETY	C291HFX4DY	PREFEST (ESTRADIOL/NORGESTIMATE) KIT [TEVA WOMEN'S HEALTH, INC.]	5
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	PREFEST (ESTRADIOL/NORGESTIMATE) KIT [TEVA WOMEN'S HEALTH, INC.]	5
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PREFEST (ESTRADIOL/NORGESTIMATE) KIT [TEVA WOMEN'S HEALTH, INC.]	5
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	PREFEST (ESTRADIOL/NORGESTIMATE) KIT [TEVA WOMEN'S HEALTH, INC.]	5
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PREFEST (ESTRADIOL/NORGESTIMATE) KIT [TEVA WOMEN'S HEALTH, INC.]	5
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	PREFEST (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 9 of 9 · 169 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
estradiol	ESTRADIOL	Zydus Lifesciences Limited	8b672c79-0896-4d6e-b225-299e89068ad7	2023-04-21		Exact identifier unii: 4TI98Z838E
Young Again	AGNUS 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 DC	b29089e4-83e1-49ab-b5dd-2ef7fbb008e3	2023-01-10	Warnings	Exact identifier unii: 4TI98Z838E
Estradiol	ESTRADIOL	Zydus Lifesciences Limited	b79fd5ea-962f-491c-b670-40efe42ccf79	2022-12-07		Exact identifier unii: 4TI98Z838E
ESTRADIOL	ESTRADIOL	Asclemed USA, Inc.	229b4ec5-d3c8-4406-9fc5-8f633c6447b8	2022-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
Estradiol	ESTRADIOL	PharmPak, Inc.	8f8c5a0b-4d7b-a5cb-e053-2995a90a494e	2022-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
HGH Vitality	AGNUS 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-fcf736643fc6	2022-03-28	Warnings	Exact identifier unii: 4TI98Z838E
GUNA-PMS	ARSENIC 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 spa	86f341b1-a8f7-4833-a1be-e51610b05bcd	2018-12-21	Warnings	Exact identifier unii: 4TI98Z838E
Lopreeza	ESTRADIOL/NORETHINDRONE ACETATE	Amneal Pharmaceuticals NY LLC	bf0e39cb-95e7-4831-92d2-0b3f071aeaae	2017-11-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 4TI98Z838E
Estrogen and Progesterone	AGNUS 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 ALBUM	ProBLEN	71fec93b-43b7-4ebb-ab5c-5f544d8e6cbf	2017-01-12	Warnings	Exact identifier unii: 4TI98Z838E

Reported adverse events (FAERS/openFDA)#

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