Clodan
- Product NDC
- 43538-950
- Requested package NDC
- 43538-950-04
- 11-digit product format
- 435380950
- Labeler code
- 43538
- Product ID
- 43538-950_d9fb3d50-fdde-4dc7-af7c-c8c2c039fc51
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- clobetasol propionate
- Dosage form
- SHAMPOO
- Route
- TOPICAL
- Labeler
- Medimetriks Pharmaceuticals
- Application
- ANDA090974
- Marketing category
- ANDA
- Marketing start
- 2014-06-22
- Substance
- CLOBETASOL PROPIONATE
- Active strength
- .5 mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 |
|---|---|---|---|---|---|---|---|
| A090974-001 | CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A090974-001 | 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.
| 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 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A090974-001 | CLOBETASOL PROPIONATE | 0.05% | SHAMPOO / TOPICAL | AB | 2012-08-09 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090974-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A090974-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A090974-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090974-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A090974-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090974-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090974-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090974-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090974-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090974-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090974-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A090974-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090974-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090974-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090974-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A090974-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090974-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090974-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090974-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090974-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090974-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090974-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090974-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090974-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090974-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090974-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090974-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090974-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090974-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090974-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A090974-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A090974-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090974-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090974-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090974-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090974-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A090974-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A090974-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090974-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A090974-001 | AB | 1 | f41ea6bd6efb… |
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
- Clodan
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CLOBETASOL PROPIONATE | .5 mg/mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 779619577M | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| b5d32546-65dc-4b0c-826e-ddbc2a50b152 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 20abe2c3-3e80-d2b2-39eb-3156e4af4799 | Product name | 3 | 20250124 |
| 45ad92f8-d116-4c0c-851c-2e740b7d8e6f | Product name | 1 | 20250122 |
| 42be0ad5-6fd7-4f1b-8108-6d9dd7d571df | Product name | 7 | 20250107 |
| 3813b789-94b9-edd6-f010-6b926dd462e5 | Product name | 5 | 20230113 |
| 30eee8a1-850e-41ed-b5ab-761301aeab49 | Product name | 6 | 20221206 |
| 18e5b6f7-c414-b1f1-b684-17fdd02c215e | Product name | 4 | 20210927 |
| 1c87bbde-dd91-a122-db33-67ae814cb645 | Product name | 7 | 20210510 |
| 519b5875-7d7d-4aa6-9d3d-470fa1376595 | Product name | 4 | 20200227 |
| 98669154-3e9c-47da-8a2c-656ab71848be | Product name | 2 | 20180607 |
| 8d4f8539-436f-453b-8b76-5322d403fc8e | Product name | 1 | 20180131 |
| 837ac3c6-ee71-c5a6-6eba-c4065f37e9f5 | Product name | 2 | 20171010 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43538-950-04 | Clodan | 1 in 1 CARTON | SHAMPOO | 1 | 5 | |
| 43538-950-04 | Clodan | 118 mL in 1 BOTTLE | SHAMPOO | 118 | 5 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 43538-950-04 | ML - Milliliter | 43538-950 | 371f855c-b251-4440-8c2b-38d39be0a289 | 1 | 2014-08-01 |
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 |
|---|---|---|---|---|---|---|
| clobetasol propionate | CLOBETASOL PROPIONATE | Padagis Israel Pharmaceuticals Ltd | 49bfff2e-9e4d-48a4-9f74-d6cf5b312aca | 2025-11-30 | Warnings, Adverse reactions | 090974 ANDA090974 |
| clobetasol propionate | CLOBETASOL PROPIONATE | Bryant Ranch Prepack | 40c3b94f-a61c-4fc1-a411-5bf4e3fe6791 | 2025-10-21 | Warnings, Adverse reactions | 090974 ANDA090974 |
| clobetasol propionate | CLOBETASOL PROPIONATE | Bryant Ranch Prepack | 2d0b48d9-dbfb-4265-b73b-07faf217ae6e | 2025-04-02 | Warnings, Adverse reactions | 090974 ANDA090974 |
| Clodan | CLOBETASOL PROPIONATE | Medimetriks Pharmaceuticals | b5d32546-65dc-4b0c-826e-ddbc2a50b152 | 2023-11-20 | Warnings, Adverse reactions | 090974 ANDA090974 43538-950-04 43538-950 43538095004 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 861490 | clobetasol propionate 0.05 % Medicated Shampoo | PSN | b5d32546-65dc-4b0c-826e-ddbc2a50b152 | 5 |
| 1541099 | Clodan 0.05 % Medicated Shampoo | PSN | b5d32546-65dc-4b0c-826e-ddbc2a50b152 | 5 |
| 1541099 | clobetasol propionate 0.5 MG/ML Medicated Shampoo [Clodan] | SBD | b5d32546-65dc-4b0c-826e-ddbc2a50b152 | 5 |
| 861490 | clobetasol propionate 0.5 MG/ML Medicated Shampoo | SCD | b5d32546-65dc-4b0c-826e-ddbc2a50b152 | 5 |
| 861490 | clobetasol propionate 0.05 % Medicated Shampoo | SY | b5d32546-65dc-4b0c-826e-ddbc2a50b152 | 5 |
| 1541099 | Clodan 0.05 % Medicated Shampoo | SY | b5d32546-65dc-4b0c-826e-ddbc2a50b152 | 5 |
| 1541099 | Clodan 0.5 MG/ML Medicated Shampoo | SY | b5d32546-65dc-4b0c-826e-ddbc2a50b152 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43538-950-04 | 43538095004 | 1 BOTTLE in 1 CARTON (43538-950-04) / 118 mL in 1 BOTTLE | 1 bottle | 2014-06-22 | 0000-00-00 | No | No | Current |