Estradiol

Product NDC: 72603-274
Requested package NDC: 72603-274-01
11-digit product format: 726030274
Labeler code: 72603
Product ID: 72603-274_435131cd-2bfc-0686-e063-6294a90a25af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Estradiol
Dosage form: TABLET
Route: ORAL
Labeler: NorthStar Rx LLC
Application: ANDA217334
Marketing category: ANDA
Marketing start: 2024-07-10
Substance: ESTRADIOL
Active strength: 1 mg/1
Pharmacologic classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A217334-001	ESTRADIOL	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06
A217334-002	ESTRADIOL	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06
A217334-003	ESTRADIOL	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A217334-001	AB
A217334-002	AB
A217334-003	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 · 60 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	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 60 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	A217334-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217334-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217334-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217334-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217334-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217334-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217334-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217334-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217334-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217334-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217334-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217334-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217334-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217334-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217334-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217334-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217334-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217334-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217334-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217334-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217334-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217334-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217334-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217334-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217334-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217334-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217334-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217334-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217334-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217334-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217334-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217334-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217334-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217334-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217334-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217334-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217334-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217334-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A217334-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A217334-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTRADIOL	1 mg/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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
197657	Internal RxNorm lookup
197658	Internal RxNorm lookup
197659	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
1c2cd11a-e010-20b2-e063-6294a90a52d5	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	Strength	SPL version
72603-274-01	Estradiol	100 in 1 BOTTLE	TABLET	100		3
72603-274-02	Estradiol	500 in 1 BOTTLE	TABLET	500		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72603-274-01	EA - Each	72603-274	90e5233e-7c72-4654-ac28-770d906a1364	1	2024-07-12
72603-274-02	EA - Each	72603-274	ed2cc205-9158-4b8a-88c2-3ddd6b84e966	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72603-274	ESTRADIOL TABLET [NORTHSTAR RX LLC]	2	Current NDC, 2 package rows	20240711_1c2cd11a-e010-20b2-e063-6294a90a52d5.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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	Redpharm Drug	5718f042-e8c0-b721-e063-6294a90a5bef	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	REMEDYREPACK INC.	41f7a56c-4ce3-4cc6-803e-1ff662efef90	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	REMEDYREPACK INC.	59a4b68d-a507-4809-a0c8-fd9799986d12	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	Preferred Pharmaceuticals, Inc.	6d129a94-8ecd-40a3-9a95-c5e1ece41ab1	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	Direct_Rx	47e446f8-ac16-ea6b-e063-6394a90a1726	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	Northwind Health Company, LLC	106b92da-334c-542f-e063-6394a90aa65b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	Northwind Health Company, LLC	0a1e744c-7926-0e0c-e063-6294a90a80d0	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	NorthStar Rx LLC	1c2cd11a-e010-20b2-e063-6294a90a52d5	2025-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334 ndc (package): 72603-274-01 ndc (product): 72603-274 ndc11 (package): 72603027401
Estradiol	ESTRADIOL	Bryant Ranch Prepack	ff3bcb07-f6fe-4582-948a-21dbf1e55f55	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	Coupler LLC	37c99e4d-fb0d-0e6e-e063-6394a90a69c8	2025-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	Preferred Pharmaceuticals Inc.	72fbd5a8-9c34-4790-84ed-79f5bd3ae0f0	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	PD-Rx Pharmaceuticals, Inc.	aa396e57-0a93-49cc-82e5-cd35c987bb0b	2025-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	A-S Medication Solutions	f7e8dd35-c12f-46be-96f9-bf9a9b6f9a90	2024-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	A-S Medication Solutions	41f424ec-9d08-4fda-b21d-41e92da6e1f0	2024-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	NuCare Pharmaceuticals,Inc.	230c2eda-b0f1-d9ec-e063-6394a90a603c	2024-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	Bryant Ranch Prepack	5e9bd73f-67db-44f9-a5ee-409eed765cd2	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	Bryant Ranch Prepack	9eb88585-4994-474f-bd63-c4e003bf6f20	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	NuCare Pharmaceuticals,Inc.	1bbdb10b-9a32-3899-e063-6294a90ab26d	2024-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	ANI Pharmaceuticals, Inc.	3fe899db-a8cd-4a31-88fb-1129be96b4d9	2024-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334

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
197657	estradiol 0.5 MG Oral Tablet	PSN	1c2cd11a-e010-20b2-e063-6294a90a52d5	3
197658	estradiol 1 MG Oral Tablet	PSN	1c2cd11a-e010-20b2-e063-6294a90a52d5	3
197659	estradiol 2 MG Oral Tablet	PSN	1c2cd11a-e010-20b2-e063-6294a90a52d5	3
197657	estradiol 0.5 MG Oral Tablet	SCD	1c2cd11a-e010-20b2-e063-6294a90a52d5	3
197658	estradiol 1 MG Oral Tablet	SCD	1c2cd11a-e010-20b2-e063-6294a90a52d5	3
197659	estradiol 2 MG Oral Tablet	SCD	1c2cd11a-e010-20b2-e063-6294a90a52d5	3
197658	estradiol 1 MG Oral Tablet	PSN	41f424ec-9d08-4fda-b21d-41e92da6e1f0	1
197658	estradiol 1 MG Oral Tablet	PSN	f7e8dd35-c12f-46be-96f9-bf9a9b6f9a90	1
197658	estradiol 1 MG Oral Tablet	SCD	41f424ec-9d08-4fda-b21d-41e92da6e1f0	1
197658	estradiol 1 MG Oral Tablet	SCD	f7e8dd35-c12f-46be-96f9-bf9a9b6f9a90	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72603-274-01	72603027401	100 TABLET in 1 BOTTLE (72603-274-01)	100 tablet	2024-07-10	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Estradiol Tablets, USP Rx only	Redpharm Drug	2026-07-21	HUMAN PRESCRIPTION DRUG LABEL	1
Estradiol Tablets, USP Rx only	NorthStar Rx LLC \| ANI Pharmaceuticals, Inc.	2025-11-11	HUMAN PRESCRIPTION DRUG LABEL	3
Estradiol Tablets, USP Rx only	A-S Medication Solutions	2024-12-30	HUMAN PRESCRIPTION DRUG LABEL	1
Estradiol Tablets, USP Rx only	A-S Medication Solutions	2024-12-30	HUMAN PRESCRIPTION DRUG LABEL	1