ESTRADIOL

Product NDC: 51655-860
Requested package NDC: 51655-860-52
11-digit product format: 516550860
Labeler code: 51655
Product ID: 51655-860_4bbc8ae6-5a91-a88b-e063-6294a90a809f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ESTRADIOL
Dosage form: TABLET
Route: ORAL
Labeler: Northwind Health Company, LLC
Application: ANDA040275
Marketing category: ANDA
Marketing start: 2023-02-09
Substance: ESTRADIOL
Active strength: .5 mg/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 · 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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A040275-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	1998-12-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040275-002	ESTRADIOL	1MG	TABLET / ORAL	AB	1998-12-29	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040275-003	ESTRADIOL	2MG	TABLET / ORAL	AB	1998-12-29	`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	A040275-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040275-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A040275-003	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 · 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 ndc (package): 51655-860-52 ndc (product): 51655-860 ndc11 (package): 51655086052
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
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTRADIOL	.5 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
197657	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
f76aff99-f415-9045-e053-6294a90afd51	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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
51655-860-26	2026-01-29	C162847	48780-1	49896155-ccfa-586f-e063-e6dba90add90	Estradiol Tablets, USP
51655-860-52	2026-01-29	C162847	48780-1	49896155-ccfa-586f-e063-e6dba90add90	Estradiol Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51655-860-26	ESTRADIOL	90 in 1 BOTTLE, PLASTIC	TABLET	90		5
51655-860-52	ESTRADIOL	30 in 1 BOTTLE, PLASTIC	TABLET	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51655-860	ESTRADIOL TABLET [NORTHWIND PHARMACEUTICALS, LLC]	2	Current NDC, 2 package rows	20230630_f76aff99-f415-9045-e053-6294a90afd51.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
197657	estradiol 0.5 MG Oral Tablet	PSN	f76aff99-f415-9045-e053-6294a90afd51	5
197657	estradiol 0.5 MG Oral Tablet	SCD	f76aff99-f415-9045-e053-6294a90afd51	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
51655-860-52	51655086052	30 TABLET in 1 BOTTLE, PLASTIC (51655-860-52)	30 tablet	2023-02-09	No	No	Current