Halobetasol Propionate
- Product NDC
- 45802-131
- Requested package NDC
- 45802-131-32
- 11-digit product format
- 458020131
- Labeler code
- 45802
- Product ID
- 45802-131_c43eed9c-3fb7-4933-ad26-9d65db4aa474
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Halobetasol Propionate
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Padagis Israel Pharmaceuticals Ltd
- Application
- ANDA076872
- Marketing category
- ANDA
- Marketing start
- 2009-02-05
- Substance
- HALOBETASOL PROPIONATE
- Active strength
- .5 mg/g
- 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 |
|---|---|---|---|---|---|---|---|
| A076872-001 | HALOBETASOL PROPIONATE | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076872-001 | 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 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | 2004-12-16 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | 2004-12-16 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | 2004-12-16 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | 2004-12-16 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | 2004-12-16 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | 2004-12-16 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | 2004-12-16 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A076872-001 | HALOBETASOL PROPIONATE | 0.05% | OINTMENT / TOPICAL | AB | RS | 2004-12-16 | 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 | A076872-001 | AB | 1 | 84e616aacf4f… |
| 2026-08-18 06:07:40 | 2026-07 | A076872-001 | AB | 1 | caaa826d4ba7… |
| 2026-02-19 14:30 UTC | 2026-02 | A076872-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076872-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076872-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076872-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076872-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076872-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076872-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076872-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076872-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076872-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076872-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076872-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076872-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076872-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076872-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076872-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076872-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076872-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A076872-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A076872-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076872-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A076872-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A076872-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A076872-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A076872-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076872-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076872-001 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076872-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A076872-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A076872-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076872-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076872-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076872-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076872-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A076872-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A076872-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A076872-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A076872-001 | 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
- Halobetasol Propionate
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HALOBETASOL PROPIONATE | .5 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 91A0K1TY3Z | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 977978 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c420da92-a3e3-4760-8cad-e50cbacebfeb | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a107c35c-2cb4-4734-a92b-e9ed5cfc34d6 | Product name | 2 | 20260220 |
| 9314f950-fe47-4276-b1f9-66d9d4a64eae | Product name | 1 | 20220217 |
| 0bc08e12-b8ed-4802-abab-926d5509afb3 | Product name | 1 | 20210513 |
| 608e9379-3a63-4bf4-b035-b393ae8faa97 | Product name | 1 | 20190214 |
| 83c1408d-b2bb-43b6-84ca-4f3e3e6f11d3 | Product name | 1 | 20151123 |
| 9badac54-f0c2-d87e-de70-c4ea0b9cf6a2 | Product name | 1 | 20140508 |
| ee2f33ab-1561-3107-e994-434cb17b4d06 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 45802-131-32 | Halobetasol Propionate | 1 in 1 CARTON | OINTMENT | 1 | 6 | |
| 45802-131-32 | Halobetasol Propionate | 50 g in 1 TUBE | OINTMENT | 50 | 6 | |
| 45802-131-35 | Halobetasol Propionate | 15 g in 1 TUBE | OINTMENT | 15 | 6 | |
| 45802-131-35 | Halobetasol Propionate | 1 in 1 CARTON | OINTMENT | 1 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 45802-131-32 | GM - Gram | 45802-131 | 3b4c4a80-e3d5-440e-84a3-e3e93fafd616 | 1 | 2012-07-24 |
| 45802-131-35 | GM - Gram | 45802-131 | 7daf1eff-93e5-4839-95dd-3a1bb2521e53 | 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 |
|---|---|---|---|---|---|---|
| Halobetasol Propionate | HALOBETASOL PROPIONATE | Bryant Ranch Prepack | 83725d7b-0788-4903-a75a-8e318ee7b568 | 2024-10-24 | Adverse reactions | 076872 ANDA076872 |
| Halobetasol Propionate | HALOBETASOL PROPIONATE | Bryant Ranch Prepack | e78c7fc9-34ba-4162-a98e-78931dc31dab | 2024-08-22 | Adverse reactions | 076872 ANDA076872 |
| Halobetasol Propionate | HALOBETASOL PROPIONATE | Bryant Ranch Prepack | be683823-9c07-498c-8357-71cbb3a3964c | 2024-03-11 | Adverse reactions | 076872 ANDA076872 |
| Halobetasol Propionate | HALOBETASOL PROPIONATE | Padagis Israel Pharmaceuticals Ltd | c420da92-a3e3-4760-8cad-e50cbacebfeb | 2022-12-31 | Adverse reactions | 076872 ANDA076872 45802-131-32 45802-131 45802013132 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 977978 | halobetasol propionate 0.05 % Topical Ointment | PSN | 83725d7b-0788-4903-a75a-8e318ee7b568 | 106 |
| 977978 | halobetasol propionate 0.0005 MG/MG Topical Ointment | SCD | 83725d7b-0788-4903-a75a-8e318ee7b568 | 106 |
| 977978 | halobetasol propionate 0.05 % Topical Ointment | SY | 83725d7b-0788-4903-a75a-8e318ee7b568 | 106 |
| 977978 | halobetasol propionate 0.05 % Topical Ointment | PSN | e78c7fc9-34ba-4162-a98e-78931dc31dab | 105 |
| 977978 | halobetasol propionate 0.0005 MG/MG Topical Ointment | SCD | e78c7fc9-34ba-4162-a98e-78931dc31dab | 105 |
| 977978 | halobetasol propionate 0.05 % Topical Ointment | SY | e78c7fc9-34ba-4162-a98e-78931dc31dab | 105 |
| 977978 | halobetasol propionate 0.05 % Topical Ointment | PSN | be683823-9c07-498c-8357-71cbb3a3964c | 103 |
| 977978 | halobetasol propionate 0.0005 MG/MG Topical Ointment | SCD | be683823-9c07-498c-8357-71cbb3a3964c | 103 |
| 977978 | halobetasol propionate 0.05 % Topical Ointment | SY | be683823-9c07-498c-8357-71cbb3a3964c | 103 |
| 977978 | halobetasol propionate 0.05 % Topical Ointment | PSN | c420da92-a3e3-4760-8cad-e50cbacebfeb | 6 |
| 977978 | halobetasol propionate 0.0005 MG/MG Topical Ointment | SCD | c420da92-a3e3-4760-8cad-e50cbacebfeb | 6 |
| 977978 | halobetasol propionate 0.05 % Topical Ointment | SY | c420da92-a3e3-4760-8cad-e50cbacebfeb | 6 |
| 977978 | halobetasol propionate 0.05 % Topical Ointment | PSN | b840b012-ef8e-4637-8e48-b1c867e7a050 | 2 |
| 977978 | halobetasol propionate 0.0005 MG/MG Topical Ointment | SCD | b840b012-ef8e-4637-8e48-b1c867e7a050 | 2 |
| 977978 | halobetasol propionate 0.05 % Topical Ointment | SY | b840b012-ef8e-4637-8e48-b1c867e7a050 | 2 |
| 977978 | halobetasol propionate 0.05 % Topical Ointment | PSN | f5304f1d-8e0d-4040-becf-ed1abf5faaa4 | 1 |
| 977978 | halobetasol propionate 0.0005 MG/MG Topical Ointment | SCD | f5304f1d-8e0d-4040-becf-ed1abf5faaa4 | 1 |
| 977978 | halobetasol propionate 0.05 % Topical Ointment | SY | f5304f1d-8e0d-4040-becf-ed1abf5faaa4 | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 45802-131-32 | 45802013132 | 1 TUBE in 1 CARTON (45802-131-32) / 50 g in 1 TUBE | 1 tube | 2009-02-05 | 0000-00-00 | No | No | Current |