Pramosone
- Product NDC
- 54766-729
- 11-digit product format
- 547660729
- Labeler code
- 54766
- Product ID
- 54766-729_4314aef2-c610-9ee4-e063-6394a90ae0ca
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocortisone acetate and pramoxine hydrochloride
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Sebela Pharmaceuticals Inc.
- Application
- ANDA085980
- Marketing category
- ANDA
- Marketing start
- 2015-07-02
- Marketing end
- 2026-12-31
- Substance
- HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
- Active strength
- 10; 10 mg/mL; mg/mL
- Pharmacologic classes
- Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pramosone
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE ACETATE | 10 mg/mL |
| PRAMOXINE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3X7931PO74, 88AYB867L5 |
| Rxcui | 1234393, 1234396 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54766-729-03 | Pramosone | 236 mL in 1 BOTTLE | LOTION | 236 | | 6 |
| 54766-729-04 | Pramosone | 118 mL in 1 BOTTLE | LOTION | 118 | | 6 |
| 54766-729-06 | Pramosone | 59 mL in 1 BOTTLE | LOTION | 59 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54766-729 | PRAMOSONE (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [SEBELA PHARMACEUTICALS INC.] | 5 | Current NDC, Legacy NDC, 3 package rows | 20241114_f207bdff-2f41-4eee-818e-198b6462863e.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54766-729-03 | 54766072903 | 236 mL in 1 BOTTLE | 236 ml | | | | | Historical |
| 54766-729-04 | 54766072904 | 118 mL in 1 BOTTLE (54766-729-04) | 118 ml | 2015-07-02 | 2026-12-31 | No | No | Current |
| 54766-729-06 | 54766072906 | 59 mL in 1 BOTTLE (54766-729-06) | 59 ml | 2015-07-02 | 0000-00-00 | No | No | Current |