FDA.reportPublic FDA data

ESTRADIOL VAGINAL INSERTS

Product NDC
59651-439
11-digit product format
596510439
Labeler code
59651
Product ID
59651-439_2df3b31e-32a6-49cd-a636-5b7779a5ed0c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
TABLET, FILM COATED
Route
VAGINAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216550
Marketing category
ANDA
Marketing start
2024-08-02
Substance
ESTRADIOL HEMIHYDRATE
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 VAGINAL INSERTS
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL HEMIHYDRATE10 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCXY7B3Q98Z
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
59651-439-08ESTRADIOL VAGINAL INSERTS1 in 1 APPLICATORTABLET, FILM COATED13
59651-439-08ESTRADIOL VAGINAL INSERTS8 in 1 CARTONTABLET, FILM COATED83
59651-439-18ESTRADIOL VAGINAL INSERTS1 in 1 APPLICATORTABLET, FILM COATED13
59651-439-18ESTRADIOL VAGINAL INSERTS18 in 1 CARTONTABLET, FILM COATED183

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-439-08EA - Each59651-43958be2a3d-e1a2-402e-9b4b-4fe1a58e797012025-02-10
59651-439-18EA - Each59651-4392bb35667-4d4b-481f-9beb-6fdc7c55a2f512025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-439ESTRADIOL VAGINAL INSERTS (ESTRADIOL) TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]2Current NDC, 4 package rows20240817_6247e329-e20e-4ea5-9cc1-b593bd494577.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884707estradiol 10 MCG Vaginal InsertPSN6247e329-e20e-4ea5-9cc1-b593bd4945773
884707estradiol 0.01 MG Vaginal InsertSCD6247e329-e20e-4ea5-9cc1-b593bd4945773
884707estradiol 10 MCG Vaginal InsertSY6247e329-e20e-4ea5-9cc1-b593bd4945773

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-439-08596510439088 APPLICATOR in 1 CARTON (59651-439-08) / 1 TABLET, FILM COATED in 1 APPLICATOR8 applicator2024-08-02NoNoCurrent
59651-439-185965104391818 APPLICATOR in 1 CARTON (59651-439-18) / 1 TABLET, FILM COATED in 1 APPLICATOR18 applicator2024-08-02NoNoCurrent