Estradiol Vaginal

Product NDC
71335-2831
11-digit product format
713352831
Labeler code
71335
Product ID
71335-2831_41dc3512-6aa7-3b33-e063-6394a90a878a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
CREAM
Route
VAGINAL
Labeler
Bryant Ranch Prepack
Application
ANDA210194
Marketing category
ANDA
Marketing start
2021-01-06
Substance
ESTRADIOL
Active strength
.1 mg/g
Pharmacologic classes
Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [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

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2831-1713352831011 TUBE in 1 CARTON (71335-2831-1) / 42.5 g in 1 TUBE1 tube2025-10-23NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ESTRADIOL VAGINAL CREAM USP, 0.01%Bryant Ranch Prepack2025-10-23HUMAN PRESCRIPTION DRUG LABEL100