Pramosone
- Product NDC
- 54766-726
- 11-digit product format
- 547660726
- Labeler code
- 54766
- Product ID
- 54766-726_4314a3cf-1fcd-f72c-e063-6294a90ac9ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocortisone acetate and pramoxine hydrochloride
- Dosage form
- LOTION
- Route
- TOPICAL
- Labeler
- Sebela Pharmaceuticals Inc.
- Application
- ANDA085979
- Marketing category
- ANDA
- Marketing start
- 2014-10-16
- Marketing end
- 2026-08-31
- Substance
- HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
- Active strength
- 25; 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 | 25 mg/mL |
| PRAMOXINE HYDROCHLORIDE | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3X7931PO74, 88AYB867L5 |
| Rxcui | 1234512, 1234514 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54766-726-04 | Pramosone | 118 mL in 1 BOTTLE, PLASTIC | LOTION | 118 | | 7 |
| 54766-726-06 | Pramosone | 59 mL in 1 BOTTLE, PLASTIC | LOTION | 59 | | 7 |
| 54766-726-75 | Pramosone | 7.5 mL in 1 BOTTLE, PLASTIC | LOTION | 7.5 | | 7 |
| 54766-726-75 | Pramosone | 12 in 1 BOX | LOTION | 12 | | 7 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54766-726 | PRAMOSONE (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) LOTION [SEBELA PHARMACEUTICALS INC.] | 6 | Current NDC, Legacy NDC, 4 package rows | 20231207_63606801-4fa8-11e4-916c-0800200c9a66.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 |
|---|
| 54766-726-04 | 54766072604 | 118 mL in 1 BOTTLE, PLASTIC (54766-726-04) | 118 ml | 2015-08-07 | 2026-08-31 | No | No | Current |
| 54766-726-06 | 54766072606 | 59 mL in 1 BOTTLE, PLASTIC (54766-726-06) | 59 ml | 2015-08-07 | 2026-08-31 | No | No | Current |
| 54766-726-75 | 54766072675 | 12 BOTTLE, PLASTIC in 1 BOX (54766-726-75) > 7.5 mL in 1 BOTTLE, PLASTIC | | 2014-10-16 | 0000-00-00 | No | No | Current |