ESTRADIOL

Product NDC
42806-089
11-digit product format
428060089
Labeler code
42806
Product ID
42806-089_2b205859-076c-1703-e063-6394a90ac140
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESTRADIOL
Dosage form
TABLET
Route
ORAL
Labeler
EPIC PHARMA, LLC
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
Rxcui197657, 197658, 197659

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42806-089-01ESTRADIOL100 in 1 BOTTLETABLET10011
42806-089-05ESTRADIOL500 in 1 BOTTLETABLET50011
42806-089-09ESTRADIOL90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-089-01EA - Each42806-08951e2eefc-e083-4775-b233-4953655ae63712017-08-11

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
42806-089ESTRADIOL TABLET [EPIC PHARMA, LLC]11Current NDC, Legacy NDC, 3 package rows20250109_9333d92f-2585-4b99-aaea-87c01c95125e.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
197657estradiol 0.5 MG Oral TabletPSN9333d92f-2585-4b99-aaea-87c01c95125e11
197658estradiol 1 MG Oral TabletPSN9333d92f-2585-4b99-aaea-87c01c95125e11
197659estradiol 2 MG Oral TabletPSN9333d92f-2585-4b99-aaea-87c01c95125e11
197657estradiol 0.5 MG Oral TabletSCD9333d92f-2585-4b99-aaea-87c01c95125e11
197658estradiol 1 MG Oral TabletSCD9333d92f-2585-4b99-aaea-87c01c95125e11
197659estradiol 2 MG Oral TabletSCD9333d92f-2585-4b99-aaea-87c01c95125e11
197659estradiol 2 MG Oral TabletPSN170ec388-d399-4543-8743-208394b389048
197659estradiol 2 MG Oral TabletSCD170ec388-d399-4543-8743-208394b389048
197657estradiol 0.5 MG Oral TabletPSN487ce40e-1f13-4497-994a-c5d91b87b6cc3
197658estradiol 1 MG Oral TabletPSN487ce40e-1f13-4497-994a-c5d91b87b6cc3
197659estradiol 2 MG Oral TabletPSN487ce40e-1f13-4497-994a-c5d91b87b6cc3
197659estradiol 2 MG Oral TabletPSN8788ddd1-36a6-416a-b527-75eb41de28083
197659estradiol 2 MG Oral TabletPSN7093dbe4-b096-2ddb-e053-2991aa0a1bb83
197657estradiol 0.5 MG Oral TabletSCD487ce40e-1f13-4497-994a-c5d91b87b6cc3
197658estradiol 1 MG Oral TabletSCD487ce40e-1f13-4497-994a-c5d91b87b6cc3
197659estradiol 2 MG Oral TabletSCD7093dbe4-b096-2ddb-e053-2991aa0a1bb83
197659estradiol 2 MG Oral TabletSCD8788ddd1-36a6-416a-b527-75eb41de28083
197659estradiol 2 MG Oral TabletSCD487ce40e-1f13-4497-994a-c5d91b87b6cc3
197657estradiol 0.5 MG Oral TabletPSN229b4ec5-d3c8-4406-9fc5-8f633c6447b82
197658estradiol 1 MG Oral TabletPSN229b4ec5-d3c8-4406-9fc5-8f633c6447b82
197659estradiol 2 MG Oral TabletPSN032135ee-7bc9-5cdf-e063-6394a90ad9a22
197659estradiol 2 MG Oral TabletPSN229b4ec5-d3c8-4406-9fc5-8f633c6447b82
197657estradiol 0.5 MG Oral TabletSCD229b4ec5-d3c8-4406-9fc5-8f633c6447b82
197658estradiol 1 MG Oral TabletSCD229b4ec5-d3c8-4406-9fc5-8f633c6447b82
197659estradiol 2 MG Oral TabletSCD229b4ec5-d3c8-4406-9fc5-8f633c6447b82
197659estradiol 2 MG Oral TabletSCD032135ee-7bc9-5cdf-e063-6394a90ad9a22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42806-089-0142806008901100 TABLET in 1 BOTTLE (42806-089-01) 100 tablet2017-04-100000-00-00NoNoCurrent
42806-089-0542806008905500 TABLET in 1 BOTTLE (42806-089-05) 500 tablet2017-04-100000-00-00NoNoCurrent
42806-089-094280600890990 TABLET in 1 BOTTLE (42806-089-09) 90 tablet2017-04-100000-00-00NoNoCurrent