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

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
A205256-001	ESTRADIOL	ESTRADIOL	10MCG	TABLET / VAGINAL	AB		2015-05-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A205256-001	AB

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	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205256-001	ESTRADIOL	10MCG	TABLET / VAGINAL	AB	2015-05-29	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A205256-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205256-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205256-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205256-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205256-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205256-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205256-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205256-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205256-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205256-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205256-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205256-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205256-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205256-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205256-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205256-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205256-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205256-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205256-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205256-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205256-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205256-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205256-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205256-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205256-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205256-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205256-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205256-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205256-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205256-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205256-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205256-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205256-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205256-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205256-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205256-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205256-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205256-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205256-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205256-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTRADIOL	10 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4TI98Z838E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
884707	Internal RxNorm lookup
1797113	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
d20abc9a-8f47-e274-c9b1-b71c9489761f	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
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	SPL version
42291-962-08	Yuvafem	8 in 1 CARTON	TABLET	8	9
42291-962-11	Yuvafem	1 in 1 APPLICATOR	TABLET	1	9
42291-962-18	Yuvafem	18 in 1 CARTON	TABLET	18	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42291-962-08	EA - Each	42291-962	1e865e1b-5df2-422c-bcdf-4889a01d7a00	1	2016-12-07
42291-962-11	EA - Each	42291-962	b6e839c4-ff41-493e-b670-a91f756e23f6	1	2025-05-14
42291-962-18	EA - Each	42291-962	cd5dff2b-a8de-4bdb-8f73-395b7066d495	1	2016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-962	YUVAFEM (ESTRADIOL) TABLET [AVKARE]	8	Current NDC, Legacy NDC, 3 package rows	20240111_d20abc9a-8f47-e274-c9b1-b71c9489761f.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Yuvafem	ESTRADIOL	AvKARE	d20abc9a-8f47-e274-c9b1-b71c9489761f	2026-01-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205256 application number: ANDA205256 ndc (product): 42291-962
YUVAFEM	ESTRADIOL	Amneal Pharmaceuticals LLC	30c7f6ba-7a9e-4853-b3e4-e00a46560224	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205256 application number: ANDA205256
Estradiol	ESTRADIOL	Amneal Pharmaceuticals of New York LLC	094830ee-1b1c-4cf7-8a39-427dfd56f9c9	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205256 application number: ANDA205256

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4TI98Z838E	ESTRADIOL	50-28-2	ESTRADIOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
884707	estradiol 10 MCG Vaginal Insert	PSN	d20abc9a-8f47-e274-c9b1-b71c9489761f	9
1797113	Yuvafem 10 MCG Vaginal Insert	PSN	d20abc9a-8f47-e274-c9b1-b71c9489761f	9
1797113	estradiol 0.01 MG Vaginal Insert [Yuvafem]	SBD	d20abc9a-8f47-e274-c9b1-b71c9489761f	9
884707	estradiol 0.01 MG Vaginal Insert	SCD	d20abc9a-8f47-e274-c9b1-b71c9489761f	9
884707	estradiol 10 MCG Vaginal Insert	SY	d20abc9a-8f47-e274-c9b1-b71c9489761f	9
1797113	Yuvafem 10 MCG (estradiol hemihydrate 10.3 MCG) Vaginal Insert	SY	d20abc9a-8f47-e274-c9b1-b71c9489761f	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42291-962-08	42291096208	8 APPLICATOR in 1 CARTON (42291-962-08) / 1 TABLET in 1 APPLICATOR (42291-962-11)	8 applicator	2016-10-19	0000-00-00	No	No	Current
42291-962-11	42291096211	1 in 1 APPLICATOR						Historical
42291-962-18	42291096218	18 APPLICATOR in 1 CARTON (42291-962-18) / 1 TABLET in 1 APPLICATOR (42291-962-11)	18 applicator	2016-10-19	0000-00-00	No	No	Current