CombiPatch (estradiol/norethindrone acetate transdermal system)
- Product NDC
- 68968-0525
- 11-digit product format
- 689680525
- Labeler code
- 68968
- Product ID
- 68968-0525_a8dddb67-4c56-4d1d-a4ce-83dc426d33f6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- estradiol/norethindrone acetate transdermal system
- Dosage form
- PATCH, EXTENDED RELEASE
- Route
- TRANSDERMAL
- Labeler
- Noven Therapeutics, LLC
- Application
- NDA020870
- Marketing category
- NDA
- Marketing start
- 1998-08-07
- Substance
- ESTRADIOL; NORETHINDRONE ACETATE
- Active strength
- .05; .25 mg/d; mg/d
- Pharmacologic classes
- Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [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 |
|---|---|---|---|---|---|---|---|
| N020870-001 | COMBIPATCH | ESTRADIOL; NORETHINDRONE ACETATE | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | |
| N020870-002 | COMBIPATCH | ESTRADIOL; NORETHINDRONE ACETATE | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020870-001 | COMBIPATCH | 0.05MG/24HR;0.14MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD | 1998-08-07 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020870-002 | COMBIPATCH | 0.05MG/24HR;0.25MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 1998-08-07 | bb7c543d1eb4… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- CombiPatch (estradiol/norethindrone acetate transdermal system)
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ESTRADIOL | .05 mg/d |
| NORETHINDRONE ACETATE | .25 mg/d |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9S44LIC7OJ | Internal UNII lookup |
| 4TI98Z838E | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 83198ef1-11c4-11e4-9191-0800200c9a66 | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68968-0525-8 | CombiPatch (estradiol/norethindrone acetate transdermal system) | 1 in 1 POUCH | PATCH, EXTENDED RELEASE | 1 | 14 | |
| 68968-0525-8 | CombiPatch (estradiol/norethindrone acetate transdermal system) | 8 in 1 CARTON | PATCH, EXTENDED RELEASE | 8 | 14 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68968-0525-1 | EA - Each | 68968-0525 | 426bc78e-9aff-4623-9ee7-ca5a00bc2452 | 1 | 2015-11-12 |
| 68968-0525-8 | EA - Each | 68968-0525 | 904abe69-ba94-4836-ba9b-23c52a280489 | 1 | 2014-10-03 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 68968-0525 | COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC] | 14 | Current NDC, Legacy NDC, 2 package rows | 20240224_83198ef1-11c4-11e4-9191-0800200c9a66.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 |
|---|---|---|---|---|---|---|
| CombiPatch (estradiol/norethindrone acetate transdermal system) | ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM | Noven Therapeutics, LLC | 83198ef1-11c4-11e4-9191-0800200c9a66 | 2024-02-21 | Boxed warning, Warnings, Adverse reactions | 020870 NDA020870 68968-0525 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1251495 | Combipatch 50/140 MCG/Day Twice Weekly Transdermal System | PSN | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
| 1251501 | Combipatch 50/250 MCG/Day Twice Weekly Transdermal System | PSN | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
| 1251493 | estradiol 50 MCG / norethindrone acetate 140 MCG/Day Twice Weekly Transdermal System | PSN | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
| 1251499 | estradiol 50 MCG / norethindrone acetate 250 MCG/Day Twice Weekly Transdermal System | PSN | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
| 1251495 | 84 HR estradiol 0.00208 MG/HR / norethindrone acetate 0.00583 MG/HR Transdermal System [Combipatch] | SBD | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
| 1251501 | 84 HR estradiol 0.00208 MG/HR / norethindrone acetate 0.0104 MG/HR Transdermal System [Combipatch] | SBD | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
| 1251493 | 84 HR estradiol 0.00208 MG/HR / norethindrone acetate 0.00583 MG/HR Transdermal System | SCD | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
| 1251499 | 84 HR estradiol 0.00208 MG/HR / norethindrone acetate 0.0104 MG/HR Transdermal System | SCD | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
| 1251495 | CombiPatch 0.05/0.14 MG per 24HR Twice Weekly Transdermal Patch | SY | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
| 1251501 | CombiPatch 0.05/0.25 MG per 24HR Twice Weekly Transdermal Patch | SY | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
| 1251495 | Combipatch 50 MCG/140 MCG/Day Twice Weekly Transdermal System | SY | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
| 1251501 | Combipatch 50/250 MCG/Day Twice Weekly Transdermal System | SY | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
| 1251495 | Combipatch 84 HR (estradiol 0.00208 MG/HR / norethindrone acetate 0.00583 MG/HR) Transdermal Patch | SY | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
| 1251501 | Combipatch 84 HR (estradiol 0.00208 MG/HR / norethindrone acetate 0.0104 MG/HR) Transdermal Patch | SY | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
| 1251493 | estradiol 0.00208 MG / norethindrone acetate 0.00583 MG per HR 84 HR Transdermal Patch | SY | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
| 1251499 | estradiol 0.00208 MG / norethindrone acetate 0.0104 MG per HR 84 HR Transdermal Patch | SY | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
| 1251493 | estradiol 0.05 MG / norethindrone acetate 0.14 MG per Day Twice Weekly Transdermal Patch | SY | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
| 1251499 | estradiol 0.05 MG / norethindrone acetate 0.25 MG per Day Twice Weekly Transdermal Patch | SY | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
| 1251493 | estradiol 50 MCG / norethindrone acetate 140 MCG/Day Twice Weekly Transdermal System | SY | 83198ef1-11c4-11e4-9191-0800200c9a66 | 14 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 68968-0525-8 | 68968052508 | 8 POUCH in 1 CARTON (68968-0525-8) / 1 PATCH in 1 POUCH / 3.5 d in 1 PATCH | 8 pouch | 1998-08-07 | 0000-00-00 | No | No | Current |