Natazia

Product NDC
50419-409
11-digit product format
504190409
Labeler code
50419
Product ID
50419-409_3b747381-9764-44a3-a08d-a80cf0988665
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estradiol valerate and estradiol valerate/dienogest
Dosage form
KIT
Labeler
Bayer HealthCare Pharmaceuticals Inc.
Application
NDA022252
Marketing category
NDA
Marketing start
2010-05-06
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Natazia
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui748797, 978941, 978944, 978946, 978948, 978949, 978950

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
50419-409-00Natazia1 in 1 BLISTER PACKKIT117
50419-409-00Natazia90 in 1 PACKAGEKIT9017
50419-409-01Natazia1 in 1 BLISTER PACKKIT117
50419-409-03Natazia3 in 1 PACKAGEKIT317
50419-409-70Natazia1 in 1 BLISTER PACKKIT117
50419-409-73Natazia5 in 1 PACKAGEKIT517
50419-409-73Natazia1 in 1 BLISTER PACKKIT117
50419-409-76Natazia2 in 1 PACKAGEKIT217

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50419-409-01EA - Each50419-409cae56fc5-9c7c-4d42-91ca-3a0be3624ed312012-07-24
50419-409-03EA - Each50419-40906c8ec2c-5e7e-4241-ba33-96c9d2a374a112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIENOGESTACTIVE INGREDIENT46M3EV8HHENATAZIA (ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]9
ESTRADIOL VALERATEACTIVE INGREDIENTOKG364O896NATAZIA (ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]9
DIENOGESTACTIVE MOIETY46M3EV8HHENATAZIA (ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]9
ESTRADIOLACTIVE MOIETY4TI98Z838ENATAZIA (ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]9
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675NATAZIA (ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]9
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTNATAZIA (ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WONATAZIA (ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XNATAZIA (ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30NATAZIA (ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]9
POLYETHYLENE GLYCOL 6000INACTIVE INGREDIENT30IQX730WENATAZIA (ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]9
POVIDONE K25INACTIVE INGREDIENTK0KQV10C35NATAZIA (ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJNATAZIA (ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]9
TALCINACTIVE INGREDIENT7SEV7J4R1UNATAZIA (ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPNATAZIA (ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50419-409NATAZIA (ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST) KIT [BAYER HEALTHCARE PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 8 package rows20240704_02c91fba-9c47-43ef-ac78-e82369798834.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
978950{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) } Pack [Natazia 28 Day]BPCK02c91fba-9c47-43ef-ac78-e8236979883417
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) } PackGPCK02c91fba-9c47-43ef-ac78-e8236979883417
978944dienogest 2 MG / estradiol valerate 2 MG Oral TabletPSN02c91fba-9c47-43ef-ac78-e8236979883417
978946dienogest 3 MG / estradiol valerate 2 MG Oral TabletPSN02c91fba-9c47-43ef-ac78-e8236979883417
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 PackPSN02c91fba-9c47-43ef-ac78-e8236979883417
978948estradiol valerate 1 MG Oral TabletPSN02c91fba-9c47-43ef-ac78-e8236979883417
978941estradiol valerate 3 MG Oral TabletPSN02c91fba-9c47-43ef-ac78-e8236979883417
748797inert 1 MG Oral TabletPSN02c91fba-9c47-43ef-ac78-e8236979883417
978950Natazia 28 Day PackPSN02c91fba-9c47-43ef-ac78-e8236979883417
978944dienogest 2 MG / estradiol valerate 2 MG Oral TabletSCD02c91fba-9c47-43ef-ac78-e8236979883417
978946dienogest 3 MG / estradiol valerate 2 MG Oral TabletSCD02c91fba-9c47-43ef-ac78-e8236979883417
978948estradiol valerate 1 MG Oral TabletSCD02c91fba-9c47-43ef-ac78-e8236979883417
978941estradiol valerate 3 MG Oral TabletSCD02c91fba-9c47-43ef-ac78-e8236979883417
748797inert ingredients 1 MG Oral TabletSCD02c91fba-9c47-43ef-ac78-e8236979883417
978950Natazia 28 Day PackSY02c91fba-9c47-43ef-ac78-e8236979883417

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50419-409-005041904090090 BLISTER PACK in 1 PACKAGE (50419-409-00) / 1 KIT in 1 BLISTER PACK90 blister pack2010-05-060000-00-00NoNoCurrent
50419-409-01504190409011 in 1 BLISTER PACKHistorical
50419-409-03504190409033 BLISTER PACK in 1 PACKAGE (50419-409-03) / 1 KIT in 1 BLISTER PACK (50419-409-01) 3 blister pack2010-05-060000-00-00NoNoCurrent
50419-409-70504190409701 in 1 BLISTER PACKHistorical
50419-409-73504190409735 BLISTER PACK in 1 PACKAGE (50419-409-73) / 1 KIT in 1 BLISTER PACK5 blister pack2010-05-060000-00-00NoNoCurrent
50419-409-76504190409762 BLISTER PACK in 1 PACKAGE (50419-409-76) / 1 KIT in 1 BLISTER PACK (50419-409-70) 2 blister pack2010-05-060000-00-00NoNoCurrent