Yuvafem

Product NDC
42291-962
11-digit product format
422910962
Labeler code
42291
Product ID
42291-962_48c2d001-2094-12ab-e063-6294a90a4f10
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
TABLET
Route
VAGINAL
Labeler
AvKARE
Application
ANDA205256
Marketing category
ANDA
Marketing start
2016-10-19
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL10 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4TI98Z838E
Rxcui884707, 1797113

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
42291-962-08Yuvafem8 in 1 CARTONTABLET89
42291-962-11Yuvafem1 in 1 APPLICATORTABLET19
42291-962-18Yuvafem18 in 1 CARTONTABLET189

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-962-08EA - Each42291-9621e865e1b-5df2-422c-bcdf-4889a01d7a0012016-12-07
42291-962-11EA - Each42291-962b6e839c4-ff41-493e-b670-a91f756e23f612025-05-14
42291-962-18EA - Each42291-962cd5dff2b-a8de-4bdb-8f73-395b7066d49512016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-962YUVAFEM (ESTRADIOL) TABLET [AVKARE]8Current NDC, Legacy NDC, 3 package rows20240111_d20abc9a-8f47-e274-c9b1-b71c9489761f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
884707estradiol 10 MCG Vaginal InsertPSNd20abc9a-8f47-e274-c9b1-b71c9489761f9
1797113Yuvafem 10 MCG Vaginal InsertPSNd20abc9a-8f47-e274-c9b1-b71c9489761f9
1797113estradiol 0.01 MG Vaginal Insert [Yuvafem]SBDd20abc9a-8f47-e274-c9b1-b71c9489761f9
884707estradiol 0.01 MG Vaginal InsertSCDd20abc9a-8f47-e274-c9b1-b71c9489761f9
884707estradiol 10 MCG Vaginal InsertSYd20abc9a-8f47-e274-c9b1-b71c9489761f9
1797113Yuvafem 10 MCG (estradiol hemihydrate 10.3 MCG) Vaginal InsertSYd20abc9a-8f47-e274-c9b1-b71c9489761f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42291-962-08422910962088 APPLICATOR in 1 CARTON (42291-962-08) / 1 TABLET in 1 APPLICATOR (42291-962-11) 8 applicator2016-10-190000-00-00NoNoCurrent
42291-962-11422910962111 in 1 APPLICATORHistorical
42291-962-184229109621818 APPLICATOR in 1 CARTON (42291-962-18) / 1 TABLET in 1 APPLICATOR (42291-962-11) 18 applicator2016-10-190000-00-00NoNoCurrent