ESTRADIOL

Product NDC
61919-195
11-digit product format
619190195
Labeler code
61919
Product ID
61919-195_92d8ecd6-6c9a-1145-e053-2995a90a4e85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESTRADIOL
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA040197
Marketing category
ANDA
Marketing start
2017-11-06
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
2020-12-31
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
61919-195-602023-01-30C16284748780-1f386c64a-27b6-0266-e053-dadaa90a7c1aESTRADIOL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-195-60ESTRADIOL60 in 1 BOTTLETABLET605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-195-60EA - Each61919-19541f1c115-c915-4cee-9d2d-1eeadb1b05e312017-12-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRADIOLACTIVE INGREDIENT4TI98Z838EESTRADIOL TABLET [DIRECTRX]1
ESTRADIOLACTIVE MOIETY4TI98Z838EESTRADIOL TABLET [DIRECTRX]1
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ESTRADIOL TABLET [DIRECTRX]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JESTRADIOL TABLET [DIRECTRX]1
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KESTRADIOL TABLET [DIRECTRX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDESTRADIOL 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
61919-195ESTRADIOL TABLET [DIRECT_RX]5Legacy NDC, 1 package rows20190919_b785a171-9d2d-425b-b812-0dddfbb4b71f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197658estradiol 1 MG Oral TabletPSNb785a171-9d2d-425b-b812-0dddfbb4b71f5
197658estradiol 1 MG Oral TabletSCDb785a171-9d2d-425b-b812-0dddfbb4b71f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-195-606191901956060 TABLET in 1 BOTTLE (61919-195-60) 60 tablet2019-09-180000-00-00NoNoCurrent