Estradiol

Product NDC: 54348-702
Requested package NDC: 54348-702-90
11-digit product format: 543480702
Labeler code: 54348
Product ID: 54348-702_ea93984c-32fa-71e9-e053-2995a90a84d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESTRADIOL
Dosage form: TABLET
Route: ORAL
Labeler: PharmPak, Inc.
Application: ANDA040197
Marketing category: ANDA
Marketing start: 2019-07-09
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

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	RLD / RS	Approval date
A040197-001	ESTRADIOL	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22
A040197-002	ESTRADIOL	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22
A040197-003	ESTRADIOL	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A040197-001	AB
A040197-002	AB
A040197-003	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A040197-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040197-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040197-003	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	REMEDYREPACK INC.	774ee81b-8e29-46af-ab12-7157f63b443b	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	Northwind Health Company, LLC	f6caf47a-1917-c493-e053-6394a90af63e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	Northwind Health Company, LLC	f6cb38ab-fdff-9c07-e053-6294a90ad59a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	PD-Rx Pharmaceuticals, Inc.	f3a77482-f490-f350-e053-2a95a90ad8cb	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	NuCare Pharmaceuticals,Inc.	c8ac2e13-58d5-4e70-e053-2995a90aff04	2025-09-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	American Health Packaging	265a1ee1-f314-4324-a2e1-0120a9a00a20	2025-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	A-S Medication Solutions	3e84e3e7-4b50-407f-a215-45363b541384	2025-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	PD-Rx Pharmaceuticals, Inc.	d0d1c2c8-b175-4250-9343-d7db65b72e8f	2025-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	NuCare Pharmaceuticals,Inc.	dd7d2d2a-e76b-7dfe-e053-2995a90a790a	2025-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	PharmPak, Inc.	20b50139-4e13-4f0c-aaf5-ecb83911d9e6	2025-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	Proficient Rx LP	7e570b07-2a9e-49bf-b224-1e34f6eda3ab	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	A-S Medication Solutions	7f3c96ce-c855-4372-95ba-7759dd82bcca	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	Bryant Ranch Prepack	80d6644a-d6f2-48e7-a685-92c4255b19fe	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	Bryant Ranch Prepack	414b846a-d6d9-4e8a-9632-12e296fc13c3	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	Teva Pharmaceuticals USA, Inc.	c4936878-1643-4e7f-9b0d-e4957935aef2	2024-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	PharmPak, Inc.	8f8c5a0b-4d7b-a5cb-e053-2995a90a494e	2022-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197 ndc (package): 54348-702-90 ndc (product): 54348-702 ndc11 (package): 54348070290

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
8f8c5a0b-4d7b-a5cb-e053-2995a90a494e	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
54348-702-90	Estradiol	90 in 1 BOTTLE	TABLET	90		2
54348-702-90	Estradiol	1 in 1 BOX	TABLET	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54348-702	ESTRADIOL TABLET [PHARMPAK, INC.]	2	Current NDC, Legacy NDC, 2 package rows	20221011_8f8c5a0b-4d7b-a5cb-e053-2995a90a494e.zip

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	8f8c5a0b-4d7b-a5cb-e053-2995a90a494e	2
197659	estradiol 2 MG Oral Tablet	SCD	8f8c5a0b-4d7b-a5cb-e053-2995a90a494e	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54348-702-90	54348070290	1 BOTTLE in 1 BOX (54348-702-90) / 90 TABLET in 1 BOTTLE	1 bottle	2019-07-09	0000-00-00	No	No	Current