Estradiol

Product NDC
64205-488
11-digit product format
642050488
Labeler code
64205
Product ID
64205-488_c89ccdc3-9d35-4d46-93f0-4de254b99040
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
TABLET
Route
ORAL
Labeler
ReadyMeds
Application
ANDA040114
Marketing category
ANDA
Marketing start
1996-03-14
Marketing end
0000-00-00
Substance
ESTRADIOL
Active strength
2 mg/1
Pharmacologic classes
Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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
64205-488-302019-11-27C16284748780-19855e2a2-422d-60a7-e053-dbdaa90a05bdEstradiol Tablets USP
64205-488-902019-11-27C16284748780-19855e2a2-422d-60a7-e053-dbdaa90a05bdEstradiol Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64205-488-30Estradiol30 in 1 BOTTLE, PLASTICTABLET303
64205-488-90Estradiol90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRADIOLACTIVE INGREDIENT4TI98Z838EESTRADIOL TABLET [READYMEDS]3
ESTRADIOLACTIVE MOIETY4TI98Z838EESTRADIOL TABLET [READYMEDS]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKESTRADIOL TABLET [READYMEDS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESTRADIOL TABLET [READYMEDS]3
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BESTRADIOL TABLET [READYMEDS]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GESTRADIOL TABLET [READYMEDS]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDESTRADIOL TABLET [READYMEDS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESTRADIOL TABLET [READYMEDS]3
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUESTRADIOL TABLET [READYMEDS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64205-488ESTRADIOL TABLET [READYMEDS]3Legacy NDC, 2 package rows20140506_3a995f9d-8b3e-4475-b818-34c4bbf4eec6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197658estradiol 1 MG Oral TabletPSN3a995f9d-8b3e-4475-b818-34c4bbf4eec63
197659estradiol 2 MG Oral TabletPSN3a995f9d-8b3e-4475-b818-34c4bbf4eec63
197658estradiol 1 MG Oral TabletSCD3a995f9d-8b3e-4475-b818-34c4bbf4eec63
197659estradiol 2 MG Oral TabletSCD3a995f9d-8b3e-4475-b818-34c4bbf4eec63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
64205-488-306420504883030 in 1 BOTTLE, PLASTICHistorical
64205-488-906420504889090 in 1 BOTTLE, PLASTICHistorical