FDA.reportPublic FDA data

Estradiol

Product NDC
71335-2892
11-digit product format
713352892
Labeler code
71335
Product ID
71335-2892_4c4007b1-f69a-4ebc-a5ed-4affea9a9d0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA217334
Marketing category
ANDA
Marketing start
2023-09-06
Substance
ESTRADIOL
Active strength
.5 mg/1
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

Additional Listing Data#

Finished product
Yes
Brand name base
Estradiol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4TI98Z838E
Rxcui197657

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379Product name220250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6Product name220250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1Product name620250311
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbfProduct name220250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1Product name320240507
66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
001f367b-fa14-49a0-865b-b395f2553601Product name220190611
3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
3ca8d96e-517a-05ea-5690-f8e1d3726540Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183Product name120140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4Product name120140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4Product name120140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2892-1Estradiol30 in 1 BOTTLETABLET301
71335-2892-2Estradiol100 in 1 BOTTLETABLET1001
71335-2892-3Estradiol90 in 1 BOTTLETABLET901
71335-2892-4Estradiol60 in 1 BOTTLETABLET601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197657estradiol 0.5 MG Oral TabletPSNff3bcb07-f6fe-4582-948a-21dbf1e55f551
197657estradiol 0.5 MG Oral TabletSCDff3bcb07-f6fe-4582-948a-21dbf1e55f551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2892-17133528920130 TABLET in 1 BOTTLE (71335-2892-1) 30 tablet2025-10-28NoNoHistorical
71335-2892-271335289202100 TABLET in 1 BOTTLE (71335-2892-2) 100 tablet2025-10-28NoNoHistorical
71335-2892-37133528920390 TABLET in 1 BOTTLE (71335-2892-3) 90 tablet2025-10-28NoNoHistorical
71335-2892-47133528920460 TABLET in 1 BOTTLE (71335-2892-4) 60 tablet2025-10-28NoNoHistorical