Climara Pro
- Product NDC
- 50419-491
- 11-digit product format
- 504190491
- Labeler code
- 50419
- Product ID
- 50419-491_9f4e7765-d4e7-4f36-9530-8b4444587214
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Estradiol and Levonorgestrel
- Dosage form
- PATCH
- Route
- TRANSDERMAL
- Labeler
- Bayer HealthCare Pharmaceuticals Inc.
- Application
- NDA021258
- Marketing category
- NDA
- Marketing start
- 2003-11-21
- Substance
- ESTRADIOL; LEVONORGESTREL
- Active strength
- .045; .015 mg/d; mg/d
- Pharmacologic classes
- Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine System [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N021258-001 | CLIMARA PRO | ESTRADIOL; LEVONORGESTREL | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N021258-001 | CLIMARA PRO | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE / TRANSDERMAL | RLD, RS | 2003-11-21 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Climara Pro
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ESTRADIOL | .045 mg/d |
| LEVONORGESTREL | .015 mg/d |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 4TI98Z838E | Internal UNII lookup |
| 5W7SIA7YZW | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 184d3092-7fc6-4375-816b-1ab06bb99cfd | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50419-491-04 | Climara Pro | 7 d in 1 PATCH | PATCH | 7 | 27 | |
| 50419-491-04 | Climara Pro | 4 in 1 CARTON | PATCH | 4 | 27 | |
| 50419-491-73 | Climara Pro | 7 d in 1 PATCH | PATCH | 7 | 27 | |
| 50419-491-73 | Climara Pro | 1 in 1 CARTON | PATCH | 1 | 27 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50419-491-04 | EA - Each | 50419-491 | c130464b-016b-40c7-8a63-69cebbb5ee5a | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Climara Pro | ESTRADIOL AND LEVONORGESTREL | Bayer HealthCare Pharmaceuticals Inc. | 184d3092-7fc6-4375-816b-1ab06bb99cfd | 2026-03-26 | Boxed warning, Warnings, Adverse reactions | 021258 NDA021258 50419-491 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 402252 | Climara Pro 0.045/0.015 MG/Day Weekly Transdermal System | PSN | 184d3092-7fc6-4375-816b-1ab06bb99cfd | 27 |
| 402250 | estradiol 0.045 MG / levonorgestrel 0.015 MG/Day Weekly Transdermal System | PSN | 184d3092-7fc6-4375-816b-1ab06bb99cfd | 27 |
| 402252 | 168 HR estradiol 0.00188 MG/HR / levonorgestrel 0.000625 MG/HR Transdermal System [Climara Pro] | SBD | 184d3092-7fc6-4375-816b-1ab06bb99cfd | 27 |
| 402250 | 168 HR estradiol 0.00188 MG/HR / levonorgestrel 0.000625 MG/HR Transdermal System | SCD | 184d3092-7fc6-4375-816b-1ab06bb99cfd | 27 |
| 402252 | Climara Pro (estradiol 0.045 MG / levonorgestrel 0.015 MG) per 24HR Weekly Transdermal Patch | SY | 184d3092-7fc6-4375-816b-1ab06bb99cfd | 27 |
| 402252 | Climara Pro 0.045/0.015 MG/Day Weekly Transdermal System | SY | 184d3092-7fc6-4375-816b-1ab06bb99cfd | 27 |
| 402250 | estradiol 0.00188 MG / levonorgestrel 0.000625 MG/HR Weekly Transdermal Patch | SY | 184d3092-7fc6-4375-816b-1ab06bb99cfd | 27 |
| 402250 | estradiol 0.045 MG / levonorgestrel 0.015 MG/Day Weekly Transdermal System | SY | 184d3092-7fc6-4375-816b-1ab06bb99cfd | 27 |
| 402250 | estradiol 45 MCG / levonorgestrel 15 MCG/Day Weekly Transdermal Patch | SY | 184d3092-7fc6-4375-816b-1ab06bb99cfd | 27 |
| 402252 | Climara Pro 0.045/0.015 MG/Day Weekly Transdermal System | PSN | eabc0fb3-da2a-482f-83a7-99b1e823a150 | 1 |
| 402250 | estradiol 0.045 MG / levonorgestrel 0.015 MG/Day Weekly Transdermal System | PSN | eabc0fb3-da2a-482f-83a7-99b1e823a150 | 1 |
| 402252 | 168 HR estradiol 0.00188 MG/HR / levonorgestrel 0.000625 MG/HR Transdermal System [Climara Pro] | SBD | eabc0fb3-da2a-482f-83a7-99b1e823a150 | 1 |
| 402250 | 168 HR estradiol 0.00188 MG/HR / levonorgestrel 0.000625 MG/HR Transdermal System | SCD | eabc0fb3-da2a-482f-83a7-99b1e823a150 | 1 |
| 402252 | Climara Pro (estradiol 0.045 MG / levonorgestrel 0.015 MG) per 24HR Weekly Transdermal Patch | SY | eabc0fb3-da2a-482f-83a7-99b1e823a150 | 1 |
| 402252 | Climara Pro 0.045/0.015 MG/Day Weekly Transdermal System | SY | eabc0fb3-da2a-482f-83a7-99b1e823a150 | 1 |
| 402250 | estradiol 0.00188 MG / levonorgestrel 0.000625 MG/HR Weekly Transdermal Patch | SY | eabc0fb3-da2a-482f-83a7-99b1e823a150 | 1 |
| 402250 | estradiol 0.045 MG / levonorgestrel 0.015 MG/Day Weekly Transdermal System | SY | eabc0fb3-da2a-482f-83a7-99b1e823a150 | 1 |
| 402250 | estradiol 45 MCG / levonorgestrel 15 MCG/Day Weekly Transdermal Patch | SY | eabc0fb3-da2a-482f-83a7-99b1e823a150 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 50419-491-04 | 50419049104 | 4 PATCH in 1 CARTON (50419-491-04) / 7 d in 1 PATCH | 4 patch | 2013-11-21 | 0000-00-00 | No | No | Current |
| 50419-491-73 | 50419049173 | 1 PATCH in 1 CARTON (50419-491-73) / 7 d in 1 PATCH | 1 patch | 2017-04-12 | 0000-00-00 | No | No | Current |