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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022252-001	NATAZIA	DIENOGEST; ESTRADIOL VALERATE	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL		RLD, RS	2010-05-06

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30
N022252-001	8153616	2028-01-30	U-1240		2012-05-09

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022252-001	NATAZIA	N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A	TABLET / ORAL	RLD, RS	2010-05-06	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022252-001	8071577	2026-05-13	U-1	Drug product	2011-12-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022252-001	8153616	2028-01-30	U-1240		2012-05-09	`782e0a99824c…`

Additional Listing Data#

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
748797	Internal RxNorm lookup
978941	Internal RxNorm lookup
978944	Internal RxNorm lookup
978946	Internal RxNorm lookup
978948	Internal RxNorm lookup
978949	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0c3ac139-af85-4c70-ad3d-981e57d86f02	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379	Product name	2	20250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6	Product name	2	20250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1	Product name	6	20250311
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbf	Product name	2	20250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1	Product name	3	20240507
66263a7f-f64d-41c4-90f1-2cee106617cc	Product name	1	20240501
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
76820076-f087-4073-b1d1-aa04b361335e	Product name	2	20220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94	Product name	3	20220126
0a040ba8-1f34-4328-bb07-4f64503daaab	Product name	2	20210513
833edb59-a012-45c2-aff5-2ed74b66fa59	Product name	1	20201207
f4d31098-441e-52d3-27f1-49c829f8a3a1	Product name	5	20190703
001f367b-fa14-49a0-865b-b395f2553601	Product name	2	20190611
3f090665-4687-4bb4-8790-8efb1930ee74	Product name	1	20180801
7a549f52-8b99-472c-8b1d-3a70c53c9bf4	Product name	1	20160623
3ca8d96e-517a-05ea-5690-f8e1d3726540	Product name	1	20140508
5f44c957-835a-ada0-662f-5b1071b7a68b	Product name	1	20140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183	Product name	1	20140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4	Product name	1	20140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4	Product name	1	20140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0781-4110-15	Estradiol Valerate and Estradiol Valerate/Dienogest	3 in 1 PACKAGE	KIT	3		5
0781-4110-52	Estradiol Valerate and Estradiol Valerate/Dienogest	1 in 1 BLISTER PACK	KIT	1		5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIENOGEST	ACTIVE INGREDIENT	46M3EV8HHE	ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]	2
ESTRADIOL VALERATE	ACTIVE INGREDIENT	OKG364O896	ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]	2
DIENOGEST	ACTIVE MOIETY	46M3EV8HHE	ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]	2
ESTRADIOL	ACTIVE MOIETY	4TI98Z838E	ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]	2
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]	2
POVIDONE K25	INACTIVE INGREDIENT	K0KQV10C35	ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0781-4110	ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST KIT [SANDOZ INC]	5	Current NDC, Legacy NDC, 2 package rows	20250212_0c3ac139-af85-4c70-ad3d-981e57d86f02.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Natazia	ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST	Bayer HealthCare Pharmaceuticals Inc.	02c91fba-9c47-43ef-ac78-e82369798834	2024-06-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022252 application number: NDA022252
Estradiol Valerate and Estradiol Valerate/Dienogest	ESTRADIOL VALERATE AND ESTRADIOL VALERATE/DIENOGEST	Sandoz Inc	0c3ac139-af85-4c70-ad3d-981e57d86f02	2020-01-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022252 application number: NDA022252 ndc (product): 0781-4110

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL 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) } Pack	GPCK	0c3ac139-af85-4c70-ad3d-981e57d86f02	5
978944	dienogest 2 MG / estradiol valerate 2 MG Oral Tablet	PSN	0c3ac139-af85-4c70-ad3d-981e57d86f02	5
978946	dienogest 3 MG / estradiol valerate 2 MG Oral Tablet	PSN	0c3ac139-af85-4c70-ad3d-981e57d86f02	5
978949	Dienogest-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 Pack	PSN	0c3ac139-af85-4c70-ad3d-981e57d86f02	5
978948	estradiol valerate 1 MG Oral Tablet	PSN	0c3ac139-af85-4c70-ad3d-981e57d86f02	5
978941	estradiol valerate 3 MG Oral Tablet	PSN	0c3ac139-af85-4c70-ad3d-981e57d86f02	5
748797	inert 1 MG Oral Tablet	PSN	0c3ac139-af85-4c70-ad3d-981e57d86f02	5
978944	dienogest 2 MG / estradiol valerate 2 MG Oral Tablet	SCD	0c3ac139-af85-4c70-ad3d-981e57d86f02	5
978946	dienogest 3 MG / estradiol valerate 2 MG Oral Tablet	SCD	0c3ac139-af85-4c70-ad3d-981e57d86f02	5
978948	estradiol valerate 1 MG Oral Tablet	SCD	0c3ac139-af85-4c70-ad3d-981e57d86f02	5
978941	estradiol valerate 3 MG Oral Tablet	SCD	0c3ac139-af85-4c70-ad3d-981e57d86f02	5
748797	inert ingredients 1 MG Oral Tablet	SCD	0c3ac139-af85-4c70-ad3d-981e57d86f02	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0781-4110-15	00781411015	3 BLISTER PACK in 1 PACKAGE (0781-4110-15) / 1 KIT in 1 BLISTER PACK (0781-4110-52)	3 blister pack	2020-01-21	0000-00-00	No	No	Current
0781-4110-52	00781411052	1 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Estradiol Valerate and Estradiol Valerate/Dienogest	Sandoz Inc \| Bayer HealthCare Pharmaceuticals Inc. \| Schering GmbH und Co. Produktions KG	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	5