ESTRADIOL

Product NDC
61919-198
11-digit product format
619190198
Labeler code
61919
Product ID
61919-198_9c93fb2a-fb02-37fa-e053-2995a90a11cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESTRADIOL
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA040197
Marketing category
ANDA
Marketing start
2019-08-12
Marketing end
0000-00-00
Substance
ESTRADIOL
Active strength
1 mg/1
Pharmacologic classes
Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
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
61919-198-602022-01-28C16284748780-1d6a99b39-521f-a426-e053-dadaa90af4c2ESTRADIOL
61919-198-302020-01-31C16284748780-19d75b9cf-cfb3-f424-e053-dadaa90a57ceESTRADIOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-198-60ESTRADIOL60 in 1 BOTTLETABLET602
61919-198-30ESTRADIOL30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-198-30EA - Each61919-198d7ac2261-0628-427e-b446-6bd5187c1cc112016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRADIOLACTIVE INGREDIENT4TI98Z838EESTRADIOL TABLET [DIRECTRX]1
ESTRADIOLACTIVE MOIETY4TI98Z838EESTRADIOL TABLET [DIRECTRX]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JESTRADIOL TABLET [DIRECTRX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XESTRADIOL TABLET [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESTRADIOL TABLET [DIRECTRX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESTRADIOL TABLET [DIRECTRX]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ESTRADIOL TABLET [DIRECTRX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESTRADIOL TABLET [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-198ESTRADIOL TABLET [DIRECT_RX]2Legacy NDC, 1 package rows20200121_8feae681-dd62-73cf-e053-2a95a90a05e8.zip
61919-198ESTRADIOL TABLET [DIRECTRX]1Legacy NDC, 1 package rows20151125_255ec9f0-d817-6b97-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197657estradiol 0.5 MG Oral TabletPSN8feae681-dd62-73cf-e053-2a95a90a05e82
197657estradiol 0.5 MG Oral TabletSCD8feae681-dd62-73cf-e053-2a95a90a05e82
197657estradiol 0.5 MG Oral TabletPSN255ec9f0-d817-6b97-e054-00144ff88e881
197657estradiol 0.5 MG Oral TabletSCD255ec9f0-d817-6b97-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-198-306191901983030 in 1 BOTTLEHistorical
61919-198-606191901986060 TABLET in 1 BOTTLE (61919-198-60) 60 tablet2019-08-120000-00-00NoNoCurrent