Estradiol

Product NDC: 0555-0886
11-digit product format: 005550886
Labeler code: 0555
Product ID: 0555-0886_e9b2e697-6e57-436a-933d-5554ca402da7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Estradiol
Dosage form: TABLET
Route: ORAL
Labeler: Teva Pharmaceuticals USA, Inc.
Application: ANDA040197
Marketing category: ANDA
Marketing start: 1997-10-28
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: 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	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.

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`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	A040197-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040197-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040197-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040197-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040197-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040197-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040197-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040197-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040197-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040197-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040197-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040197-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040197-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040197-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040197-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040197-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040197-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040197-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040197-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040197-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040197-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040197-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040197-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040197-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040197-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040197-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040197-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040197-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040197-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040197-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040197-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040197-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040197-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040197-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040197-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040197-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040197-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040197-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040197-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040197-001	AB	1	`8072bd15b7f6…`

Additional Listing Data#

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

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
c4936878-1643-4e7f-9b0d-e4957935aef2	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
0555-0886-02	Estradiol	100 in 1 BOTTLE	TABLET	100		16
0555-0886-04	Estradiol	500 in 1 BOTTLE	TABLET	500		16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0555-0886-02	EA - Each	0555-0886	9053a198-2be3-4d27-b22e-739e243a5a01	1	2013-02-13
0555-0886-04	EA - Each	0555-0886	f24357ae-856e-42cf-b97b-d3223b0c490e	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ESTRADIOL	ACTIVE INGREDIENT	4TI98Z838E	ESTRADIOL TABLET [BARR LABORATORIES INC.]	4
ESTRADIOL	ACTIVE MOIETY	4TI98Z838E	ESTRADIOL TABLET [BARR LABORATORIES INC.]	4
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	ESTRADIOL TABLET [BARR LABORATORIES INC.]	4
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	ESTRADIOL TABLET [BARR LABORATORIES INC.]	4
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	ESTRADIOL TABLET [BARR LABORATORIES INC.]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ESTRADIOL TABLET [BARR LABORATORIES INC.]	4
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	ESTRADIOL TABLET [BARR LABORATORIES INC.]	4
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ESTRADIOL TABLET [BARR LABORATORIES INC.]	4
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESTRADIOL TABLET [BARR LABORATORIES INC.]	4
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESTRADIOL TABLET [BARR LABORATORIES INC.]	4
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ESTRADIOL TABLET [BARR LABORATORIES INC.]	4
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ESTRADIOL TABLET [BARR LABORATORIES INC.]	4
ESTRADIOL	ACTIVE INGREDIENT	4TI98Z838E	ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
ESTRADIOL	ACTIVE MOIETY	4TI98Z838E	ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
ANHYDROUS DIBASIC CALCIUM PHOSPHATE	INACTIVE INGREDIENT	L11K75P92J	ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ESTRADIOL TABLET [PHYSICIANS TOTAL CARE, INC.]	2
ESTRADIOL	ACTIVE INGREDIENT	4TI98Z838E	ESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
ESTRADIOL	ACTIVE MOIETY	4TI98Z838E	ESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	ESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	ESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
D&C RED NO. 27	INACTIVE INGREDIENT	2LRS185U6K	ESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	ESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	ESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	ESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	ESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ESTRADIOL TABLET [AIDAREX PHARMACEUTICALS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0555-0886	ESTRADIOL TABLET [TEVA PHARMACEUTICALS USA, INC.]	15	Current NDC, Legacy NDC, 2 package rows	20240308_c4936878-1643-4e7f-9b0d-e4957935aef2.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 · 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 ndc (product): 0555-0886
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

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	3e84e3e7-4b50-407f-a215-45363b541384	31
197658	estradiol 1 MG Oral Tablet	PSN	3e84e3e7-4b50-407f-a215-45363b541384	31
197659	estradiol 2 MG Oral Tablet	PSN	3e84e3e7-4b50-407f-a215-45363b541384	31
197657	estradiol 0.5 MG Oral Tablet	SCD	3e84e3e7-4b50-407f-a215-45363b541384	31
197658	estradiol 1 MG Oral Tablet	SCD	3e84e3e7-4b50-407f-a215-45363b541384	31
197659	estradiol 2 MG Oral Tablet	SCD	3e84e3e7-4b50-407f-a215-45363b541384	31
197657	estradiol 0.5 MG Oral Tablet	PSN	80d6644a-d6f2-48e7-a685-92c4255b19fe	17
197658	estradiol 1 MG Oral Tablet	PSN	80d6644a-d6f2-48e7-a685-92c4255b19fe	17
197659	estradiol 2 MG Oral Tablet	PSN	80d6644a-d6f2-48e7-a685-92c4255b19fe	17
197657	estradiol 0.5 MG Oral Tablet	SCD	80d6644a-d6f2-48e7-a685-92c4255b19fe	17
197658	estradiol 1 MG Oral Tablet	SCD	80d6644a-d6f2-48e7-a685-92c4255b19fe	17
197659	estradiol 2 MG Oral Tablet	SCD	80d6644a-d6f2-48e7-a685-92c4255b19fe	17
197657	estradiol 0.5 MG Oral Tablet	PSN	c4936878-1643-4e7f-9b0d-e4957935aef2	16
197658	estradiol 1 MG Oral Tablet	PSN	c4936878-1643-4e7f-9b0d-e4957935aef2	16
197659	estradiol 2 MG Oral Tablet	PSN	c4936878-1643-4e7f-9b0d-e4957935aef2	16
197657	estradiol 0.5 MG Oral Tablet	SCD	c4936878-1643-4e7f-9b0d-e4957935aef2	16
197658	estradiol 1 MG Oral Tablet	SCD	c4936878-1643-4e7f-9b0d-e4957935aef2	16
197659	estradiol 2 MG Oral Tablet	SCD	c4936878-1643-4e7f-9b0d-e4957935aef2	16
197658	estradiol 1 MG Oral Tablet	PSN	f3a77482-f490-f350-e053-2a95a90ad8cb	8
197658	estradiol 1 MG Oral Tablet	SCD	f3a77482-f490-f350-e053-2a95a90ad8cb	8
197658	estradiol 1 MG Oral Tablet	PSN	7e570b07-2a9e-49bf-b224-1e34f6eda3ab	6
197658	estradiol 1 MG Oral Tablet	SCD	7e570b07-2a9e-49bf-b224-1e34f6eda3ab	6
197658	estradiol 1 MG Oral Tablet	PSN	f6cb38ab-fdff-9c07-e053-6294a90ad59a	4
197658	estradiol 1 MG Oral Tablet	SCD	f6cb38ab-fdff-9c07-e053-6294a90ad59a	4
197658	estradiol 1 MG Oral Tablet	PSN	7f3c96ce-c855-4372-95ba-7759dd82bcca	3
197658	estradiol 1 MG Oral Tablet	PSN	20b50139-4e13-4f0c-aaf5-ecb83911d9e6	3
197658	estradiol 1 MG Oral Tablet	SCD	7f3c96ce-c855-4372-95ba-7759dd82bcca	3
197658	estradiol 1 MG Oral Tablet	SCD	20b50139-4e13-4f0c-aaf5-ecb83911d9e6	3
197657	estradiol 0.5 MG Oral Tablet	PSN	37f3094c-f02d-4a9c-8e30-2c4752bc62ed	2
197658	estradiol 1 MG Oral Tablet	PSN	8735213f-9d8d-6300-e053-2991aa0afb81	2
197658	estradiol 1 MG Oral Tablet	PSN	265a1ee1-f314-4324-a2e1-0120a9a00a20	2
197658	estradiol 1 MG Oral Tablet	PSN	c8ac2e13-58d5-4e70-e053-2995a90aff04	2
197658	estradiol 1 MG Oral Tablet	PSN	37f3094c-f02d-4a9c-8e30-2c4752bc62ed	2
197659	estradiol 2 MG Oral Tablet	PSN	37f3094c-f02d-4a9c-8e30-2c4752bc62ed	2
197657	estradiol 0.5 MG Oral Tablet	SCD	37f3094c-f02d-4a9c-8e30-2c4752bc62ed	2
197658	estradiol 1 MG Oral Tablet	SCD	37f3094c-f02d-4a9c-8e30-2c4752bc62ed	2
197658	estradiol 1 MG Oral Tablet	SCD	c8ac2e13-58d5-4e70-e053-2995a90aff04	2
197658	estradiol 1 MG Oral Tablet	SCD	265a1ee1-f314-4324-a2e1-0120a9a00a20	2
197658	estradiol 1 MG Oral Tablet	SCD	8735213f-9d8d-6300-e053-2991aa0afb81	2
197659	estradiol 2 MG Oral Tablet	SCD	37f3094c-f02d-4a9c-8e30-2c4752bc62ed	2
197658	estradiol 1 MG Oral Tablet	PSN	7712c639-36c5-4c0f-aa74-fd4161540761	1
197658	estradiol 1 MG Oral Tablet	PSN	8febb45d-a1fc-702c-e053-2995a90a3e62	1
197658	estradiol 1 MG Oral Tablet	PSN	d1f09c5c-8f31-0911-e053-2a95a90af1b8	1
197659	estradiol 2 MG Oral Tablet	PSN	7712c639-36c5-4c0f-aa74-fd4161540761	1
197658	estradiol 1 MG Oral Tablet	SCD	8febb45d-a1fc-702c-e053-2995a90a3e62	1
197658	estradiol 1 MG Oral Tablet	SCD	d1f09c5c-8f31-0911-e053-2a95a90af1b8	1
197658	estradiol 1 MG Oral Tablet	SCD	7712c639-36c5-4c0f-aa74-fd4161540761	1
197659	estradiol 2 MG Oral Tablet	SCD	7712c639-36c5-4c0f-aa74-fd4161540761	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0555-0886-02	00555088602	100 TABLET in 1 BOTTLE (0555-0886-02)	100 tablet	1997-10-28	0000-00-00	No	No	Current
0555-0886-04	00555088604	500 TABLET in 1 BOTTLE (0555-0886-04)	500 tablet	1997-10-28	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Estradiol Tablets, USP	Northwind Health Company, LLC	2026-01-01	HUMAN PRESCRIPTION DRUG LABEL	4
Estradiol Tablets, USP	PD-Rx Pharmaceuticals, Inc.	2025-10-09	HUMAN PRESCRIPTION DRUG LABEL	8
Estradiol Tablets USP	NuCare Pharmaceuticals,Inc.	2025-09-22	HUMAN PRESCRIPTION DRUG LABEL	2
Estradiol Tablets, USP	REMEDYREPACK INC.	2025-06-02	HUMAN PRESCRIPTION DRUG LABEL	14
Estradiol Tablets, USP Rx only 8487665/0924F	American Health Packaging	2025-05-02	HUMAN PRESCRIPTION DRUG LABEL	2
Estradiol Tablets, USP	A-S Medication Solutions	2025-04-15	HUMAN PRESCRIPTION DRUG LABEL	31
Estradiol Tablets USP	PharmPak, Inc.	2025-01-16	HUMAN PRESCRIPTION DRUG LABEL	3
Estradiol Tablets USP	Proficient Rx LP	2024-10-01	HUMAN PRESCRIPTION DRUG LABEL	6
Estradiol Tablets, USP	A-S Medication Solutions	2024-07-18	HUMAN PRESCRIPTION DRUG LABEL	3
Estradiol Tablets, USP	REMEDYREPACK INC.	2024-04-16	HUMAN PRESCRIPTION DRUG LABEL	6
Estradiol Tablets, USP	Bryant Ranch Prepack	2024-04-05	HUMAN PRESCRIPTION DRUG LABEL	17
Estradiol Tablets, USP	Teva Pharmaceuticals USA, Inc.	2024-02-01	HUMAN PRESCRIPTION DRUG LABEL	16
Estradiol Tablets USP	Preferred Pharmaceuticals Inc.	2023-05-24	HUMAN PRESCRIPTION DRUG LABEL	3
Estradiol Tablets USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-11-29	HUMAN PRESCRIPTION DRUG LABEL	1
Estradiol Tablets USP	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-06-02	HUMAN PRESCRIPTION DRUG LABEL	2
Estradiol Tablets USP	NuCare Pharmaceuticals, Inc \| NuCare Pharmaceuticals, Inc.	2020-01-21	HUMAN PRESCRIPTION DRUG LABEL	2
ESTRADIOL	Direct_Rx	2019-08-12	HUMAN PRESCRIPTION DRUG LABEL	1
Estradiol Tablets USP	NuCare Pharmaceuticals,Inc.	2017-12-19	HUMAN PRESCRIPTION DRUG LABEL	1
ESTRADIOL TABLETS, USP	Aidarex Pharmaceuticals LLC	2013-12-31	HUMAN PRESCRIPTION DRUG LABEL	1
Estradiol - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2010-06-09	HUMAN PRESCRIPTION DRUG LABEL	2