DOTTI
- Product NDC
- 72162-2035
- Requested package NDC
- 72162-2035-2
- 11-digit product format
- 721622035
- Labeler code
- 72162
- Product ID
- 72162-2035_1b1ed832-032e-405d-b3ef-cd88afac5210
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Bryant Ranch Prepack
- Application
- ANDA211293
- Marketing category
- ANDA
- Marketing start
- 2019-02-04
- Substance
- ESTRADIOL
- Active strength
- .075 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
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | 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#
| 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211293-001 | ESTRADIOL | 0.025MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2019-02-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211293-002 | ESTRADIOL | 0.0375MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2019-02-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211293-003 | ESTRADIOL | 0.05MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2019-02-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211293-004 | ESTRADIOL | 0.075MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2019-02-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A211293-005 | ESTRADIOL | 0.1MG/24HR | SYSTEM / TRANSDERMAL | AB1 | 2019-02-04 | 84e616aacf4f… | |
| 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… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A211293-001 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211293-002 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211293-003 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211293-004 | AB1 | 1 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | A211293-005 | AB1 | 1 | 84e616aacf4f… |
| 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… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DOTTI
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ESTRADIOL | .075 mg/d |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4TI98Z838E | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b119df4a-c514-4804-b1a8-b09c6058e80d | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 72162-2035-2 | DOTTI | 8 in 1 CARTON | PATCH, EXTENDED RELEASE | 8 | 102 | |
| 72162-2035-4 | DOTTI | 1 d in 1 POUCH | PATCH, EXTENDED RELEASE | 1 | 102 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 72162-2035-2 | EA - Each | 72162-2035 | 99be2de3-92f5-47d2-aa3d-dd3e615feb64 | 1 | 2023-08-08 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 72162-2035 | DOTTI (ESTRADIOL) PATCH, EXTENDED RELEASE [BRYANT RANCH PREPACK] | 102 | Current NDC, 2 package rows | 20240830_b119df4a-c514-4804-b1a8-b09c6058e80d.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.
| 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 | 211293 ANDA211293 |
| DOTTI | ESTRADIOL | Bryant Ranch Prepack | b119df4a-c514-4804-b1a8-b09c6058e80d | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 211293 ANDA211293 72162-2035-2 72162-2035 72162203502 |
| DOTTI | ESTRADIOL | Bryant Ranch Prepack | f419192a-eb95-4087-9fe0-0eea639ef51b | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 211293 ANDA211293 |
| DOTTI | ESTRADIOL | Bryant Ranch Prepack | 779751dc-243a-4dc2-ae67-3669f196b205 | 2024-08-12 | Boxed warning, Warnings, Adverse reactions | 211293 ANDA211293 |
| DOTTI | ESTRADIOL | Bryant Ranch Prepack | 99b889a0-6200-4727-97d3-f5a0b7814e1b | 2024-07-17 | Boxed warning, Warnings, Adverse reactions | 211293 ANDA211293 |
| Estradiol | ESTRADIOL | Amneal Pharmaceuticals NY LLC | 0500ee9b-bf4a-4432-9afe-20a7d60a6fe5 | 2024-05-14 | Boxed warning, Warnings, Adverse reactions | 211293 ANDA211293 |
| DOTTI | ESTRADIOL | Amneal Pharmaceuticals LLC | 53016d30-6b5f-49da-ac16-85ef415a5805 | 2024-05-14 | Boxed warning, Warnings, Adverse reactions | 211293 ANDA211293 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2110783 | DOTTI 0.075 MG/Day Twice Weekly Transdermal System | PSN | b119df4a-c514-4804-b1a8-b09c6058e80d | 102 |
| 1149632 | estradiol 0.075 MG/Day Twice Weekly Transdermal System | PSN | b119df4a-c514-4804-b1a8-b09c6058e80d | 102 |
| 2110783 | 84 HR estradiol 0.00313 MG/HR Transdermal System [Dotti] | SBD | b119df4a-c514-4804-b1a8-b09c6058e80d | 102 |
| 1149632 | 84 HR estradiol 0.00313 MG/HR Transdermal System | SCD | b119df4a-c514-4804-b1a8-b09c6058e80d | 102 |
| 2110783 | 84 HR Dotti 0.00313 MG/HR Transdermal System | SY | b119df4a-c514-4804-b1a8-b09c6058e80d | 102 |
| 2110783 | Dotti 0.075 MG/24HR Twice Weekly Transdermal System | SY | b119df4a-c514-4804-b1a8-b09c6058e80d | 102 |
| 1149632 | estradiol 0.00313 MG/HR 84 HR Transdermal Patch | SY | b119df4a-c514-4804-b1a8-b09c6058e80d | 102 |
| 1149632 | estradiol 0.075 MG/Day Twice Weekly Transdermal System | SY | b119df4a-c514-4804-b1a8-b09c6058e80d | 102 |
| 1149632 | estradiol 75 MCG/Day Twice Weekly Transdermal Patch | SY | b119df4a-c514-4804-b1a8-b09c6058e80d | 102 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 72162-2035-2 | 72162203502 | 8 POUCH in 1 CARTON (72162-2035-2) / 1 d in 1 POUCH (72162-2035-4) | 8 pouch | 2019-02-04 | No | No | Current |