FDA.reportPublic FDA data

ESTRADIOL

Product NDC
63629-4788
11-digit product format
636294788
Labeler code
63629
Product ID
63629-4788_4b89b496-5d2d-4a60-bac8-5e00f5104672
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESTRADIOL
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040275
Marketing category
ANDA
Marketing start
2017-04-10
Substance
ESTRADIOL
Active strength
2 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
ESTRADIOL2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4TI98Z838E
Rxcui197659

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
63629-4788-12025-03-25C16284748780-19d75b9d1-0f1e-f424-e053-dadaa90a57ceEstradiol Tablets, USP
63629-4788-22025-03-25C16284748780-19d75b9d1-0f1e-f424-e053-dadaa90a57ceEstradiol Tablets, USP
63629-4788-32025-03-25C16284748780-19d75b9d1-0f1e-f424-e053-dadaa90a57ceEstradiol Tablets, USP
63629-4788-42025-03-25C16284748780-19d75b9d1-0f1e-f424-e053-dadaa90a57ceEstradiol Tablets, USP
63629-4788-52025-03-25C16284748780-19d75b9d1-0f1e-f424-e053-dadaa90a57ceEstradiol Tablets, USP
63629-4788-12024-01-30C16284748780-19d75b9d1-0f1e-f424-e053-dadaa90a57ceEstradiol Tablets, USP
63629-4788-22024-01-30C16284748780-19d75b9d1-0f1e-f424-e053-dadaa90a57ceEstradiol Tablets, USP
63629-4788-32024-01-30C16284748780-19d75b9d1-0f1e-f424-e053-dadaa90a57ceEstradiol Tablets, USP
63629-4788-42024-01-30C16284748780-19d75b9d1-0f1e-f424-e053-dadaa90a57ceEstradiol Tablets, USP
63629-4788-52024-01-30C16284748780-19d75b9d1-0f1e-f424-e053-dadaa90a57ceEstradiol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-4788-1ESTRADIOL30 in 1 BOTTLETABLET301021
63629-4788-2ESTRADIOL15 in 1 BOTTLETABLET151021
63629-4788-3ESTRADIOL90 in 1 BOTTLETABLET901021
63629-4788-4ESTRADIOL60 in 1 BOTTLETABLET601021
63629-4788-5ESTRADIOL100 in 1 BOTTLETABLET1001021

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRADIOLACTIVE INGREDIENT4TI98Z838EESTRADIOL TABLET [BRYANT RANCH PREPACK]1002
ESTRADIOLACTIVE MOIETY4TI98Z838EESTRADIOL TABLET [BRYANT RANCH PREPACK]1002
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKESTRADIOL TABLET [BRYANT RANCH PREPACK]1002
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESTRADIOL TABLET [BRYANT RANCH PREPACK]1002
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GESTRADIOL TABLET [BRYANT RANCH PREPACK]1002
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDESTRADIOL TABLET [BRYANT RANCH PREPACK]1002
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESTRADIOL TABLET [BRYANT RANCH PREPACK]1002
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUESTRADIOL TABLET [BRYANT RANCH PREPACK]1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-4788ESTRADIOL TABLET [BRYANT RANCH PREPACK]1021Current NDC, Legacy NDC, 5 package rows20250327_bfc1beb9-1ade-446e-97dd-55b41c2fa851.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197659estradiol 2 MG Oral TabletPSNbfc1beb9-1ade-446e-97dd-55b41c2fa8511021
197659estradiol 2 MG Oral TabletSCDbfc1beb9-1ade-446e-97dd-55b41c2fa8511021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-4788-16362947880130 TABLET in 1 BOTTLE (63629-4788-1) 30 tablet2021-12-220000-00-00NoNoCurrent
63629-4788-26362947880215 TABLET in 1 BOTTLE (63629-4788-2) 15 tablet2021-12-220000-00-00NoNoCurrent
63629-4788-36362947880390 TABLET in 1 BOTTLE (63629-4788-3) 90 tablet2021-12-220000-00-00NoNoCurrent
63629-4788-46362947880460 TABLET in 1 BOTTLE (63629-4788-4) 60 tablet2021-12-220000-00-00NoNoCurrent
63629-4788-563629478805100 TABLET in 1 BOTTLE (63629-4788-5) 100 tablet2017-10-090000-00-00NoNoCurrent