Estradiol Valerate and Estradiol Valerate/Dienogest

Product NDC
0781-4110
11-digit product format
007814110
Labeler code
0781
Product ID
0781-4110_ce80046e-2aca-4c57-af85-d985e3ae769f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estradiol valerate and estradiol valerate/dienogest
Dosage form
KIT
Labeler
Sandoz Inc
Application
NDA022252
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2015-08-05
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Estradiol Valerate and Estradiol Valerate/Dienogest
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui748797, 978941, 978944, 978946, 978948, 978949

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
0781-4110-15Estradiol Valerate and Estradiol Valerate/Dienogest3 in 1 PACKAGEKIT35
0781-4110-52Estradiol Valerate and Estradiol Valerate/Dienogest1 in 1 BLISTER PACKKIT15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIENOGESTACTIVE INGREDIENT46M3EV8HHEESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]2
ESTRADIOL VALERATEACTIVE INGREDIENTOKG364O896ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]2
DIENOGESTACTIVE MOIETY46M3EV8HHEESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]2
ESTRADIOLACTIVE MOIETY4TI98Z838EESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]2
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]2
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WEESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]2
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]2
TALCINACTIVE INGREDIENT7SEV7J4R1UESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-4110ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]5Current NDC, Legacy NDC, 2 package rows20250212_0c3ac139-af85-4c70-ad3d-981e57d86f02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978949{5 (dienogest 2 MG / estradiol valerate 2 MG Oral Tablet) / 17 (dienogest 3 MG / estradiol valerate 2 MG Oral Tablet) / 2 (estradiol valerate 1 MG Oral Tablet) / 2 (estradiol valerate 3 MG Oral Tablet) / 2 (inert ingredients 1 MG Oral Tablet) } PackGPCK0c3ac139-af85-4c70-ad3d-981e57d86f025
978944dienogest 2 MG / estradiol valerate 2 MG Oral TabletPSN0c3ac139-af85-4c70-ad3d-981e57d86f025
978946dienogest 3 MG / estradiol valerate 2 MG Oral TabletPSN0c3ac139-af85-4c70-ad3d-981e57d86f025
978949Dienogest-Estra val 2 MG (5) Oral Tablet / Dienogest-Estra val 2 MG (17) Oral Tablet / Estra val 1 MG (2) Oral Tablet / Estra val 3 MG (2) Oral Tablet / Inert 1 MG (2) Oral Tablet 28 Day PackPSN0c3ac139-af85-4c70-ad3d-981e57d86f025
978948estradiol valerate 1 MG Oral TabletPSN0c3ac139-af85-4c70-ad3d-981e57d86f025
978941estradiol valerate 3 MG Oral TabletPSN0c3ac139-af85-4c70-ad3d-981e57d86f025
748797inert 1 MG Oral TabletPSN0c3ac139-af85-4c70-ad3d-981e57d86f025
978944dienogest 2 MG / estradiol valerate 2 MG Oral TabletSCD0c3ac139-af85-4c70-ad3d-981e57d86f025
978946dienogest 3 MG / estradiol valerate 2 MG Oral TabletSCD0c3ac139-af85-4c70-ad3d-981e57d86f025
978948estradiol valerate 1 MG Oral TabletSCD0c3ac139-af85-4c70-ad3d-981e57d86f025
978941estradiol valerate 3 MG Oral TabletSCD0c3ac139-af85-4c70-ad3d-981e57d86f025
748797inert ingredients 1 MG Oral TabletSCD0c3ac139-af85-4c70-ad3d-981e57d86f025

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0781-4110-15007814110153 BLISTER PACK in 1 PACKAGE (0781-4110-15) / 1 KIT in 1 BLISTER PACK (0781-4110-52) 3 blister pack2020-01-210000-00-00NoNoCurrent
0781-4110-52007814110521 in 1 BLISTER PACKHistorical