FDA.reportPublic FDA data

ESTRADIOL

Product NDC
50090-5494
11-digit product format
500905494
Labeler code
50090
Product ID
50090-5494_6677d43b-5536-408e-b568-6b0565c2b3b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESTRADIOL
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA040275
Marketing category
ANDA
Marketing start
2017-04-10
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5494-02023-02-07C16284748780-1f386c64a-2bee-0266-e053-dadaa90a7c1aEstradiol Tablets, USP
50090-5494-12023-02-07C16284748780-1f386c64a-2bee-0266-e053-dadaa90a7c1aEstradiol Tablets, USP
50090-5494-02023-01-30C16284748780-1f386c64a-2bee-0266-e053-dadaa90a7c1aEstradiol Tablets, USP
50090-5494-12023-01-30C16284748780-1f386c64a-2bee-0266-e053-dadaa90a7c1aEstradiol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5494-0ESTRADIOL30 in 1 BOTTLETABLET309
50090-5494-1ESTRADIOL90 in 1 BOTTLETABLET909

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5494-0EA - Each50090-5494c6754f2e-b267-4e44-bdde-4f23fd4be95012023-03-13
50090-5494-1EA - Each50090-5494a531ed7e-44d3-4950-ad18-ea754dbc2ef612023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5494ESTRADIOL TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 2 package rows20250110_376beb31-5fed-4aae-a16f-71a7d243d5eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197657estradiol 0.5 MG Oral TabletPSN376beb31-5fed-4aae-a16f-71a7d243d5eb9
197657estradiol 0.5 MG Oral TabletSCD376beb31-5fed-4aae-a16f-71a7d243d5eb9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5494-05009054940030 TABLET in 1 BOTTLE (50090-5494-0) 30 tablet2021-03-170000-00-00NoNoCurrent
50090-5494-15009054940190 TABLET in 1 BOTTLE (50090-5494-1) 90 tablet2021-03-170000-00-00NoNoCurrent