Estradiol

Product NDC
0093-3223
11-digit product format
000933223
Labeler code
0093
Product ID
0093-3223_c9460fad-4385-488b-8253-b7a4a44683d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
INSERT
Route
VAGINAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA206388
Marketing category
ANDA
Marketing start
2017-07-24
Substance
ESTRADIOL
Active strength
10 ug/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
ESTRADIOL10 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4TI98Z838E
Rxcui884707

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
0093-3223-08Estradiol1 in 1 BLISTER PACKINSERT113
0093-3223-08Estradiol8 in 1 CARTONINSERT813
0093-3223-19Estradiol1 in 1 BLISTER PACKINSERT113
0093-3223-19Estradiol1 in 1 APPLICATORINSERT113
0093-3223-97Estradiol18 in 1 CARTONINSERT1813

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3223-08EA - Each0093-322348006dc0-c76e-475e-991d-2fe2297a5ce912017-08-11
0093-3223-19EA - Each0093-32239defe270-615a-4b38-88bd-f168ffdd767412017-08-11
0093-3223-97EA - Each0093-32236299b03e-3e1b-4898-9992-361efa5d7ebf12017-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3223ESTRADIOL INSERT [TEVA PHARMACEUTICALS USA, INC.]13Current NDC, Legacy NDC, 5 package rows20250214_8cb31c7c-fba8-4201-833d-844ea1a8a4de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884707estradiol 10 MCG Vaginal InsertPSN7eb1b2c3-8ece-47c3-96c0-606f7f5b5a32103
884707estradiol 10 MCG Vaginal InsertPSNd9514497-6b9e-4c13-950b-6b036ff101c1103
884707estradiol 0.01 MG Vaginal InsertSCD7eb1b2c3-8ece-47c3-96c0-606f7f5b5a32103
884707estradiol 0.01 MG Vaginal InsertSCDd9514497-6b9e-4c13-950b-6b036ff101c1103
884707estradiol 10 MCG Vaginal InsertSY7eb1b2c3-8ece-47c3-96c0-606f7f5b5a32103
884707estradiol 10 MCG Vaginal InsertSYd9514497-6b9e-4c13-950b-6b036ff101c1103
884707estradiol 10 MCG Vaginal InsertPSN8cb31c7c-fba8-4201-833d-844ea1a8a4de13
884707estradiol 0.01 MG Vaginal InsertSCD8cb31c7c-fba8-4201-833d-844ea1a8a4de13
884707estradiol 10 MCG Vaginal InsertSY8cb31c7c-fba8-4201-833d-844ea1a8a4de13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0093-3223-08000933223088 BLISTER PACK in 1 CARTON (0093-3223-08) / 1 APPLICATOR in 1 BLISTER PACK / 1 INSERT in 1 APPLICATOR8 blister pack2017-07-240000-00-00NoNoCurrent
0093-3223-19000933223191 in 1 BLISTER PACKHistorical
0093-3223-970009332239718 BLISTER PACK in 1 CARTON (0093-3223-97) / 1 APPLICATOR in 1 BLISTER PACK (0093-3223-19) / 1 INSERT in 1 APPLICATOR18 blister pack2017-07-240000-00-00NoNoCurrent