DIPROLENE
- Product NDC
- 78206-124
- 11-digit product format
- 782060124
- Labeler code
- 78206
- Product ID
- 78206-124_35f40d2c-b958-4c7a-88b1-47b1790996ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- betamethasone dipropionate
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Organon LLC
- Application
- NDA018741
- Marketing category
- NDA
- Marketing start
- 2021-06-01
- Substance
- BETAMETHASONE DIPROPIONATE
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DIPROLENE
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| BETAMETHASONE DIPROPIONATE | .5 mg/g |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | 826Y60901U |
| Rxcui | 848180, 848200 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dde7b902-54a1-627e-12f1-9e6d244ab88c | Product name | 4 | 20250317 |
| 69b49899-11cf-4f7e-bd0a-7dc93b27311b | Product name | 3 | 20250130 |
| bbdc14c7-d940-43b5-a2f7-36c425991f3c | Product name | 1 | 20240320 |
| 0a2fcc35-464b-9ec2-a622-753662cdd48c | Product name | 3 | 20240216 |
| 6f762601-17ef-4321-8f47-77783d3c4d8b | Product name | 3 | 20231116 |
| 1dbefad7-ab34-69c3-e51a-e7148aa38f70 | Product name | 5 | 20220921 |
| 7fea2046-07a9-4bb6-9409-828ac6f1f6df | Product name | 1 | 20210201 |
| f059f1a2-0e64-4839-9a7f-42687c91a44b | Product name | 1 | 20201007 |
| 4ea9e4b5-b452-48ad-9b25-b9a4d403405d | Product name | 1 | 20160310 |
| f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6 | Product name | 2 | 20151106 |
| 4f07db9b-3707-3e2c-05b5-d7852ba808c4 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 78206-124-01 | DIPROLENE | 1 in 1 BOX | OINTMENT | 1 | 3 | |
| 78206-124-01 | DIPROLENE | 15 g in 1 TUBE | OINTMENT | 15 | 3 | |
| 78206-124-02 | DIPROLENE | 1 in 1 BOX | OINTMENT | 1 | 3 | |
| 78206-124-02 | DIPROLENE | 50 g in 1 TUBE | OINTMENT | 50 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 78206-124-01 | GM - Gram | 78206-124 | 342a2698-af17-464d-b7a3-2ce6b8b9d900 | 1 | 2021-10-08 |
| 78206-124-02 | GM - Gram | 78206-124 | f1a0e34b-0bf0-44e8-829d-4cfe40a284f6 | 1 | 2021-10-08 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 848180 | betamethasone dipropionate 0.05 % Augmented Topical Ointment | PSN | 0b9543ad-2ca7-430d-aef9-81c376dc2e6c | 3 |
| 848200 | Diprolene 0.05 % Topical Ointment | PSN | 0b9543ad-2ca7-430d-aef9-81c376dc2e6c | 3 |
| 848200 | Augmented betamethasone 0.0005 MG/MG Topical Ointment [Diprolene] | SBD | 0b9543ad-2ca7-430d-aef9-81c376dc2e6c | 3 |
| 848180 | Augmented betamethasone 0.0005 MG/MG Topical Ointment | SCD | 0b9543ad-2ca7-430d-aef9-81c376dc2e6c | 3 |
| 848180 | augmented betamethasone 0.05 % Topical Ointment | SY | 0b9543ad-2ca7-430d-aef9-81c376dc2e6c | 3 |
| 848200 | Augmented Diprolene 0.0005 MG/MG Topical Ointment | SY | 0b9543ad-2ca7-430d-aef9-81c376dc2e6c | 3 |
| 848180 | betamethasone 0.05 % Augmented Topical Ointment | SY | 0b9543ad-2ca7-430d-aef9-81c376dc2e6c | 3 |
| 848180 | betamethasone 0.5 MG/GM (betamethasone dipropionate 0.64 MG/GM) Augmented Topical Ointment | SY | 0b9543ad-2ca7-430d-aef9-81c376dc2e6c | 3 |
| 848200 | Diprolene (betamethasone dipropionate) 0.05 % Augmented Topical Ointment | SY | 0b9543ad-2ca7-430d-aef9-81c376dc2e6c | 3 |
| 848200 | Diprolene 0.0005 MG/MG Augmented Topical Ointment | SY | 0b9543ad-2ca7-430d-aef9-81c376dc2e6c | 3 |
| 848200 | Diprolene 0.5 MG/ML (betamethasone dipropionate 0.64 MG/ML) Augmented Topical Ointment | SY | 0b9543ad-2ca7-430d-aef9-81c376dc2e6c | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 78206-124-01 | 78206012401 | 1 TUBE in 1 BOX (78206-124-01) / 15 g in 1 TUBE | 1 tube | 2021-06-01 | 0000-00-00 | No | No | Current |
| 78206-124-02 | 78206012402 | 1 TUBE in 1 BOX (78206-124-02) / 50 g in 1 TUBE | 1 tube | 2021-06-01 | 0000-00-00 | No | No | Current |