Etyqa

Product NDC
59651-425
11-digit product format
596510425
Labeler code
59651
Product ID
59651-425_50c8c596-e201-4370-8487-421925c60b4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESTRADIOL AND NORETHINDRONE ACETATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA214729
Marketing category
ANDA
Marketing start
2023-06-30
Substance
ESTRADIOL; NORETHINDRONE ACETATE
Active strength
.5; .1 mg/1; mg/1
Pharmacologic classes
Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
4TI98Z838EESTRADIOL50-28-2ESTRADIOL
9S44LIC7OJNORETHINDRONE ACETATE51-98-9NORETHINDRONE ACETATE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-425-28596510425281 BLISTER PACK in 1 CARTON (59651-425-28) / 28 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2023-06-30NoNoHistorical
59651-425-87596510425871 POUCH in 1 CARTON (59651-425-87) / 1 BLISTER PACK in 1 POUCH / 28 TABLET, FILM COATED in 1 BLISTER PACK1 pouch2023-06-30NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
EtyqaAurobindo Pharma Limited2024-03-01Human Prescription Drug Label2