ESTRADIOL

Product NDC: 63629-4788
Requested package NDC: 63629-4788-4
11-digit product format: 636294788
Labeler code: 63629
Product ID: 63629-4788_4b89b496-5d2d-4a60-bac8-5e00f5104672
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESTRADIOL
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA040275
Marketing category: ANDA
Marketing start: 2017-04-10
Substance: ESTRADIOL
Active strength: 2 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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 13 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A040275-001	ESTRADIOL	ESTRADIOL	0.5MG	TABLET / ORAL	AB	1998-12-29
A040275-002	ESTRADIOL	ESTRADIOL	1MG	TABLET / ORAL	AB	1998-12-29
A040275-003	ESTRADIOL	ESTRADIOL	2MG	TABLET / ORAL	AB	1998-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040275-001	AB
A040275-002	AB
A040275-003	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 4 · 123 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	A040275-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	1998-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040275-002	ESTRADIOL	1MG	TABLET / ORAL	AB	1998-12-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040275-003	ESTRADIOL	2MG	TABLET / ORAL	AB	1998-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040275-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	1998-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040275-002	ESTRADIOL	1MG	TABLET / ORAL	AB	1998-12-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040275-003	ESTRADIOL	2MG	TABLET / ORAL	AB	1998-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040275-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	1998-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040275-002	ESTRADIOL	1MG	TABLET / ORAL	AB	1998-12-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040275-003	ESTRADIOL	2MG	TABLET / ORAL	AB	1998-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040275-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	1998-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040275-002	ESTRADIOL	1MG	TABLET / ORAL	AB	1998-12-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040275-003	ESTRADIOL	2MG	TABLET / ORAL	AB	1998-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040275-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	1998-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040275-002	ESTRADIOL	1MG	TABLET / ORAL	AB	1998-12-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040275-003	ESTRADIOL	2MG	TABLET / ORAL	AB	1998-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040275-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	1998-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040275-002	ESTRADIOL	1MG	TABLET / ORAL	AB	1998-12-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040275-003	ESTRADIOL	2MG	TABLET / ORAL	AB	1998-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040275-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	1998-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040275-002	ESTRADIOL	1MG	TABLET / ORAL	AB	1998-12-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040275-003	ESTRADIOL	2MG	TABLET / ORAL	AB	1998-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040275-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	1998-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040275-002	ESTRADIOL	1MG	TABLET / ORAL	AB	1998-12-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040275-003	ESTRADIOL	2MG	TABLET / ORAL	AB	1998-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040275-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	1998-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040275-002	ESTRADIOL	1MG	TABLET / ORAL	AB	1998-12-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040275-003	ESTRADIOL	2MG	TABLET / ORAL	AB	1998-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040275-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	1998-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040275-002	ESTRADIOL	1MG	TABLET / ORAL	AB	1998-12-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040275-003	ESTRADIOL	2MG	TABLET / ORAL	AB	1998-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040275-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	1998-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040275-002	ESTRADIOL	1MG	TABLET / ORAL	AB	1998-12-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040275-003	ESTRADIOL	2MG	TABLET / ORAL	AB	1998-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040275-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	1998-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040275-002	ESTRADIOL	1MG	TABLET / ORAL	AB	1998-12-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040275-003	ESTRADIOL	2MG	TABLET / ORAL	AB	1998-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040275-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	1998-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040275-002	ESTRADIOL	1MG	TABLET / ORAL	AB	1998-12-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040275-003	ESTRADIOL	2MG	TABLET / ORAL	AB	1998-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040275-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	1998-12-29	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A040275-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040275-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040275-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040275-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040275-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040275-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040275-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040275-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040275-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040275-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040275-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040275-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040275-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040275-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040275-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040275-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040275-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040275-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040275-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040275-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040275-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040275-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040275-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040275-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040275-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040275-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040275-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040275-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040275-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040275-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040275-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040275-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040275-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040275-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040275-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040275-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040275-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040275-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040275-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040275-001	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	2 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
bfc1beb9-1ade-446e-97dd-55b41c2fa851	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
63629-4788-1	2025-03-25	Estradiol Tablets, USP
63629-4788-2	2025-03-25	Estradiol Tablets, USP
63629-4788-3	2025-03-25	Estradiol Tablets, USP
63629-4788-4	2025-03-25	Estradiol Tablets, USP
63629-4788-5	2025-03-25	Estradiol Tablets, USP
63629-4788-1	2024-01-30	Estradiol Tablets, USP
63629-4788-2	2024-01-30	Estradiol Tablets, USP
63629-4788-3	2024-01-30	Estradiol Tablets, USP
63629-4788-4	2024-01-30	Estradiol Tablets, USP
63629-4788-5	2024-01-30	Estradiol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63629-4788-1	ESTRADIOL	30 in 1 BOTTLE	TABLET	30	1021
63629-4788-2	ESTRADIOL	15 in 1 BOTTLE	TABLET	15	1021
63629-4788-3	ESTRADIOL	90 in 1 BOTTLE	TABLET	90	1021
63629-4788-4	ESTRADIOL	60 in 1 BOTTLE	TABLET	60	1021
63629-4788-5	ESTRADIOL	100 in 1 BOTTLE	TABLET	100	1021

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESTRADIOL	ACTIVE INGREDIENT	4TI98Z838E	ESTRADIOL TABLET [BRYANT RANCH PREPACK]	1002
ESTRADIOL	ACTIVE MOIETY	4TI98Z838E	ESTRADIOL TABLET [BRYANT RANCH PREPACK]	1002
ANHYDROUS LACTOSE	INACTIVE INGREDIENT	3SY5LH9PMK	ESTRADIOL TABLET [BRYANT RANCH PREPACK]	1002
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ESTRADIOL TABLET [BRYANT RANCH PREPACK]	1002
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	ESTRADIOL TABLET [BRYANT RANCH PREPACK]	1002
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ESTRADIOL TABLET [BRYANT RANCH PREPACK]	1002
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESTRADIOL TABLET [BRYANT RANCH PREPACK]	1002
POLACRILIN POTASSIUM	INACTIVE INGREDIENT	0BZ5A00FQU	ESTRADIOL TABLET [BRYANT RANCH PREPACK]	1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63629-4788	ESTRADIOL TABLET [BRYANT RANCH PREPACK]	1021	Current NDC, Legacy NDC, 5 package rows	20250327_bfc1beb9-1ade-446e-97dd-55b41c2fa851.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	A-S Medication Solutions	5c9a2e0f-704b-4d16-8ea3-d94f7f36ce6b	2026-07-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275
ESTRADIOL	ESTRADIOL	REMEDYREPACK INC.	477cb52e-8ce2-491f-94a0-869ff60bf7ab	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275
ESTRADIOL	ESTRADIOL	A-S Medication Solutions	afd70875-0a93-40a7-842e-f4359818c2d9	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275
ESTRADIOL	ESTRADIOL	REMEDYREPACK INC.	170ec388-d399-4543-8743-208394b38904	2026-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275
ESTRADIOL	ESTRADIOL	Northwind Health Company, LLC	f76aff99-f415-9045-e053-6294a90afd51	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275
ESTRADIOL	ESTRADIOL	Preferred Pharmaceuticals Inc.	9956a196-fefd-4766-a225-e154fbd3aeff	2025-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275
ESTRADIOL	ESTRADIOL	Bryant Ranch Prepack	fad3813c-9495-416b-9789-623d5758b4e3	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275
ESTRADIOL	ESTRADIOL	Bryant Ranch Prepack	cf1ebc1d-8f3c-4468-b565-f0da69986e7c	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275
ESTRADIOL	ESTRADIOL	Bryant Ranch Prepack	bfc1beb9-1ade-446e-97dd-55b41c2fa851	2025-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275 ndc (package): 63629-4788-4 ndc (product): 63629-4788 ndc11 (package): 63629478804
ESTRADIOL	ESTRADIOL	A-S Medication Solutions	8788ddd1-36a6-416a-b527-75eb41de2808	2025-02-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275
ESTRADIOL	ESTRADIOL	Asclemed USA, Inc.	487ce40e-1f13-4497-994a-c5d91b87b6cc	2025-02-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275
Estradiol	ESTRADIOL	Direct_Rx	032135ee-7bc9-5cdf-e063-6394a90ad9a2	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275
Estradiol	ESTRADIOL	Direct_Rx	01789bad-4be4-ae22-e063-6294a90af392	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275
ESTRADIOL	ESTRADIOL	A-S Medication Solutions	376beb31-5fed-4aae-a16f-71a7d243d5eb	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275
ESTRADIOL	ESTRADIOL	PURACAP LABORATORIES, LLC	97ace322-341a-4d52-8c63-17265ed9aa8d	2025-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275
ESTRADIOL	ESTRADIOL	EPIC PHARMA, LLC	9333d92f-2585-4b99-aaea-87c01c95125e	2025-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275
ESTRADIOL	ESTRADIOL	NuCare Pharmaceuticals, Inc.	5423c0da-eb10-20cd-e054-00144ff8d46c	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275
ESTRADIOL	ESTRADIOL	NuCare Pharmaceuticals,Inc.	7093dbe4-b096-2ddb-e053-2991aa0a1bb8	2024-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275
ESTRADIOL	ESTRADIOL	Asclemed USA, Inc.	229b4ec5-d3c8-4406-9fc5-8f633c6447b8	2022-10-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040275 application number: ANDA040275

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
197659	estradiol 2 MG Oral Tablet	PSN	bfc1beb9-1ade-446e-97dd-55b41c2fa851	1021
197659	estradiol 2 MG Oral Tablet	SCD	bfc1beb9-1ade-446e-97dd-55b41c2fa851	1021

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63629-4788-4	63629478804	60 TABLET in 1 BOTTLE (63629-4788-4)	60 tablet	2021-12-22	0000-00-00	No	No	Current