DOTTI

Product NDC: 65162-997
11-digit product format: 651620997
Labeler code: 65162
Product ID: 65162-997_d26f45d5-79c5-429a-bb0f-44c58fa0b569
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Estradiol
Dosage form: PATCH, EXTENDED RELEASE
Route: TRANSDERMAL
Labeler: Amneal Pharmaceuticals LLC
Application: ANDA211293
Marketing category: ANDA
Marketing start: 2019-02-04
Substance: ESTRADIOL
Active strength: .1 mg/d
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 42.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A211293-001	ESTRADIOL	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04
A211293-002	ESTRADIOL	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04
A211293-003	ESTRADIOL	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04
A211293-004	ESTRADIOL	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04
A211293-005	ESTRADIOL	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
A211293-001	AB1
A211293-002	AB1
A211293-003	AB1
A211293-004	AB1
A211293-005	AB1

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 6 · 210 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
2026-08-18 06:07:40	2026-07	A211293-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211293-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211293-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211293-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211293-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211293-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211293-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211293-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211293-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211293-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211293-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211293-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211293-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211293-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211293-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-001	ESTRADIOL	0.025MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-002	ESTRADIOL	0.0375MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-003	ESTRADIOL	0.05MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-004	ESTRADIOL	0.075MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-005	ESTRADIOL	0.1MG/24HR	SYSTEM / TRANSDERMAL	AB1	2019-02-04	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211293-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211293-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211293-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211293-004	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211293-005	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211293-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211293-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211293-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211293-004	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211293-005	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-004	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211293-005	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211293-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211293-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211293-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211293-004	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211293-005	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-004	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211293-005	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-004	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211293-005	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-004	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211293-005	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-004	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211293-005	AB1	1	`2680178bc6a6…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTRADIOL	.1 mg/d

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 · 10 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
241946	Internal RxNorm lookup
242891	Internal RxNorm lookup
242892	Internal RxNorm lookup
248478	Internal RxNorm lookup
1149632	Internal RxNorm lookup
2110774	Internal RxNorm lookup
2110777	Internal RxNorm lookup
2110780	Internal RxNorm lookup
2110783	Internal RxNorm lookup
2110786	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
53016d30-6b5f-49da-ac16-85ef415a5805	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
65162-997-04	DOTTI	1 d in 1 POUCH	PATCH, EXTENDED RELEASE	1		10
65162-997-08	DOTTI	8 in 1 CARTON	PATCH, EXTENDED RELEASE	8		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-997-04	EA - Each	65162-997	8be37ef0-9919-47c5-9081-db40fd61e5f6	1	2019-07-02
65162-997-08	EA - Each	65162-997	0cd59a56-f260-45b3-b6ae-3f90de0ddd53	1	2019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-997	DOTTI (ESTRADIOL) PATCH, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]	10	Current NDC, Legacy NDC, 2 package rows	20240607_53016d30-6b5f-49da-ac16-85ef415a5805.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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOTTI	ESTRADIOL	Bryant Ranch Prepack	75fc6d3a-49b6-47ad-b704-410692010d3a	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211293 application number: ANDA211293
DOTTI	ESTRADIOL	Bryant Ranch Prepack	b119df4a-c514-4804-b1a8-b09c6058e80d	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211293 application number: ANDA211293
DOTTI	ESTRADIOL	Bryant Ranch Prepack	f419192a-eb95-4087-9fe0-0eea639ef51b	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211293 application number: ANDA211293
DOTTI	ESTRADIOL	Bryant Ranch Prepack	779751dc-243a-4dc2-ae67-3669f196b205	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211293 application number: ANDA211293
DOTTI	ESTRADIOL	Bryant Ranch Prepack	99b889a0-6200-4727-97d3-f5a0b7814e1b	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211293 application number: ANDA211293
Estradiol	ESTRADIOL	Amneal Pharmaceuticals NY LLC	0500ee9b-bf4a-4432-9afe-20a7d60a6fe5	2024-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211293 application number: ANDA211293
DOTTI	ESTRADIOL	Amneal Pharmaceuticals LLC	53016d30-6b5f-49da-ac16-85ef415a5805	2024-05-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211293 application number: ANDA211293 ndc (product): 65162-997

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
2110786	DOTTI 0.1 MG/Day Twice Weekly Transdermal System	PSN	779751dc-243a-4dc2-ae67-3669f196b205	102
242892	estradiol 0.1 MG/Day Twice Weekly Transdermal System	PSN	779751dc-243a-4dc2-ae67-3669f196b205	102
2110786	84 HR estradiol 0.00417 MG/HR Transdermal System [Dotti]	SBD	779751dc-243a-4dc2-ae67-3669f196b205	102
242892	84 HR estradiol 0.00417 MG/HR Transdermal System	SCD	779751dc-243a-4dc2-ae67-3669f196b205	102
2110786	84 HR Dotti 0.00417 MG/HR Transdermal System	SY	779751dc-243a-4dc2-ae67-3669f196b205	102
2110786	Dotti 0.1 MG/24HR Twice Weekly Transdermal System	SY	779751dc-243a-4dc2-ae67-3669f196b205	102
242892	estradiol 0.00417 MG/HR 84 HR Transdermal Patch	SY	779751dc-243a-4dc2-ae67-3669f196b205	102
242892	estradiol 0.1 MG/24HR Twice Weekly Transdermal Patch	SY	779751dc-243a-4dc2-ae67-3669f196b205	102
242892	estradiol 0.1 MG/Day Twice Weekly Transdermal System	SY	779751dc-243a-4dc2-ae67-3669f196b205	102
2110774	DOTTI 0.025 MG/Day Twice Weekly Transdermal System	PSN	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110777	DOTTI 0.0375 MG/Day Twice Weekly Transdermal System	PSN	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110780	DOTTI 0.05 MG/Day Twice Weekly Transdermal System	PSN	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110783	DOTTI 0.075 MG/Day Twice Weekly Transdermal System	PSN	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110786	DOTTI 0.1 MG/Day Twice Weekly Transdermal System	PSN	53016d30-6b5f-49da-ac16-85ef415a5805	10
248478	estradiol 0.025 MG/Day Twice Weekly Transdermal System	PSN	53016d30-6b5f-49da-ac16-85ef415a5805	10
241946	estradiol 0.0375 MG/Day Twice Weekly Transdermal System	PSN	53016d30-6b5f-49da-ac16-85ef415a5805	10
242891	estradiol 0.05 MG/Day Twice Weekly Transdermal System	PSN	53016d30-6b5f-49da-ac16-85ef415a5805	10
1149632	estradiol 0.075 MG/Day Twice Weekly Transdermal System	PSN	53016d30-6b5f-49da-ac16-85ef415a5805	10
242892	estradiol 0.1 MG/Day Twice Weekly Transdermal System	PSN	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110774	84 HR estradiol 0.00104 MG/HR Transdermal System [Dotti]	SBD	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110777	84 HR estradiol 0.00156 MG/HR Transdermal System [Dotti]	SBD	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110780	84 HR estradiol 0.00208 MG/HR Transdermal System [Dotti]	SBD	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110783	84 HR estradiol 0.00313 MG/HR Transdermal System [Dotti]	SBD	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110786	84 HR estradiol 0.00417 MG/HR Transdermal System [Dotti]	SBD	53016d30-6b5f-49da-ac16-85ef415a5805	10
248478	84 HR estradiol 0.00104 MG/HR Transdermal System	SCD	53016d30-6b5f-49da-ac16-85ef415a5805	10
241946	84 HR estradiol 0.00156 MG/HR Transdermal System	SCD	53016d30-6b5f-49da-ac16-85ef415a5805	10
242891	84 HR estradiol 0.00208 MG/HR Transdermal System	SCD	53016d30-6b5f-49da-ac16-85ef415a5805	10
1149632	84 HR estradiol 0.00313 MG/HR Transdermal System	SCD	53016d30-6b5f-49da-ac16-85ef415a5805	10
242892	84 HR estradiol 0.00417 MG/HR Transdermal System	SCD	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110774	84 HR Dotti 0.00104 MG/HR Transdermal System	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110777	84 HR Dotti 0.00156 MG/HR Transdermal System	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110780	84 HR Dotti 0.00208 MG/HR Transdermal System	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110783	84 HR Dotti 0.00313 MG/HR Transdermal System	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110786	84 HR Dotti 0.00417 MG/HR Transdermal System	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110774	Dotti 0.025 MG/24HR Twice Weekly Transdermal System	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110777	Dotti 0.0375 MG/24HR Twice Weekly Transdermal System	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110780	Dotti 0.05 MG/24HR Twice Weekly Transdermal System	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110783	Dotti 0.075 MG/24HR Twice Weekly Transdermal System	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
2110786	Dotti 0.1 MG/24HR Twice Weekly Transdermal System	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
248478	estradiol 0.00104 MG/HR 84 HR Transdermal Patch	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
241946	estradiol 0.00156 MG/HR 84 HR Transdermal Patch	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
242891	estradiol 0.00208 MG/HR 84 HR Transdermal Patch	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
1149632	estradiol 0.00313 MG/HR 84 HR Transdermal Patch	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
242892	estradiol 0.00417 MG/HR 84 HR Transdermal Patch	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
248478	estradiol 0.025 MG/Day Twice Weekly Transdermal Patch	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
248478	estradiol 0.025 MG/Day Twice Weekly Transdermal System	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
241946	estradiol 0.0375 MG/Day Twice Weekly Transdermal System	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
242891	estradiol 0.05 MG/Day Twice Weekly Transdermal System	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
1149632	estradiol 0.075 MG/Day Twice Weekly Transdermal System	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
242892	estradiol 0.1 MG/24HR Twice Weekly Transdermal Patch	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
242892	estradiol 0.1 MG/Day Twice Weekly Transdermal System	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
241946	estradiol 37.5 MCG/Day Twice Weekly Transdermal Patch	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
242891	estradiol 50 MCG/Day Twice Weekly Transdermal Patch	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10
1149632	estradiol 75 MCG/Day Twice Weekly Transdermal Patch	SY	53016d30-6b5f-49da-ac16-85ef415a5805	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-997-04	65162099704	1 d in 1 POUCH	1 d					Historical
65162-997-08	65162099708	8 POUCH in 1 CARTON (65162-997-08) / 1 d in 1 POUCH (65162-997-04)	8 pouch	2019-02-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOTTI - Bryant Ranch Prepack	Bryant Ranch Prepack	2024-08-12	HUMAN PRESCRIPTION DRUG LABEL	102
DOTTI - Amneal Pharmaceuticals LLC	Amneal Pharmaceuticals LLC	2024-05-14	HUMAN PRESCRIPTION DRUG LABEL	10