FDA.reportPublic FDA data

Estradiol

Product NDC
68788-8626
11-digit product format
687888626
Labeler code
68788
Product ID
68788-8626_b178ce8e-d12f-4a03-b69e-8d48a2ee2d66
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA217334
Marketing category
ANDA
Marketing start
2024-04-09
Substance
ESTRADIOL
Active strength
.5 mg/1
Pharmacologic classes
Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Estradiol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4TI98Z838E
Rxcui197657

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8626-1Estradiol100 in 1 BOTTLETABLET1003
68788-8626-3Estradiol30 in 1 BOTTLETABLET303
68788-8626-6Estradiol60 in 1 BOTTLETABLET603
68788-8626-9Estradiol90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8626-1EA - Each68788-862683509970-055c-4706-b80d-1cce47ca205912024-06-10
68788-8626-3EA - Each68788-86266f53b0c3-49e4-427b-b474-eb8d36351b6e12024-06-10
68788-8626-6EA - Each68788-86268d37d1f8-d878-4242-a295-c5e158245e6712024-06-10
68788-8626-9EA - Each68788-8626ecad338d-d639-409e-a644-cddcb6a4645e12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8626ESTRADIOL TABLET [PREFERRED PHARMACEUTICALS, INC.]2Current NDC, 4 package rows20250503_6d129a94-8ecd-40a3-9a95-c5e1ece41ab1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197657estradiol 0.5 MG Oral TabletPSN6d129a94-8ecd-40a3-9a95-c5e1ece41ab13
197657estradiol 0.5 MG Oral TabletSCD6d129a94-8ecd-40a3-9a95-c5e1ece41ab13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8626-168788862601100 TABLET in 1 BOTTLE (68788-8626-1) 100 tablet2024-04-09NoNoHistorical
68788-8626-36878886260330 TABLET in 1 BOTTLE (68788-8626-3) 30 tablet2024-04-09NoNoHistorical
68788-8626-66878886260660 TABLET in 1 BOTTLE (68788-8626-6) 60 tablet2024-04-09NoNoHistorical
68788-8626-96878886260990 TABLET in 1 BOTTLE (68788-8626-9) 90 tablet2024-04-09NoNoHistorical