FDA.reportPublic FDA data

estradiol

Product NDC
68382-323
11-digit product format
683820323
Labeler code
68382
Product ID
68382-323_1e54d575-0530-4304-8a50-3ffaf3c124d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estradiol
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA204379
Marketing category
ANDA
Marketing start
2023-11-02
Substance
ESTRADIOL
Active strength
.014 mg/d
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
ESTRADIOL.014 mg/d

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4TI98Z838E
Rxcui476545

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
68382-323-01estradiol1 in 1 POUCHPATCH12
68382-323-01estradiol7 d in 1 PATCHPATCH72
68382-323-04estradiol4 in 1 CARTONPATCH42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-323ESTRADIOL PATCH [ZYDUS PHARMACEUTICALS USA INC.]2Current NDC, 3 package rows20240321_684850eb-d889-4370-a0a7-4a5c3113266a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
476545estradiol 14 MCG/Day Weekly Transdermal SystemPSN684850eb-d889-4370-a0a7-4a5c3113266a2
476545168 HR estradiol 0.000583 MG/HR Transdermal SystemSCD684850eb-d889-4370-a0a7-4a5c3113266a2
476545estradiol 0.000583 MG/HR Weekly Transdermal PatchSY684850eb-d889-4370-a0a7-4a5c3113266a2
476545estradiol 14 MCG/Day Weekly Transdermal PatchSY684850eb-d889-4370-a0a7-4a5c3113266a2
476545estradiol 14 MCG/Day Weekly Transdermal SystemSY684850eb-d889-4370-a0a7-4a5c3113266a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68382-323-01683820323011 in 1 POUCHHistorical
68382-323-04683820323044 POUCH in 1 CARTON (68382-323-04) / 1 PATCH in 1 POUCH (68382-323-01) / 7 d in 1 PATCH4 pouch2023-11-02NoNoCurrent