Pramosone Cream
- Product NDC
- 54766-716
- 11-digit product format
- 547660716
- Labeler code
- 54766
- Product ID
- 54766-716_431495fb-6225-9c16-e063-6394a90a14ba
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocortisone acetate and pramoxine hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sebela Pharmaceuticals Inc.
- Application
- ANDA085368
- Marketing category
- ANDA
- Marketing start
- 2015-08-04
- Marketing end
- 2026-07-31
- Substance
- HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
- Active strength
- 10; 10 mg/g; mg/g
- 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 Cream
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HYDROCORTISONE ACETATE | 10 mg/g |
| PRAMOXINE HYDROCHLORIDE | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3X7931PO74, 88AYB867L5 |
| Rxcui | 1116499, 1234519 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54766-716-03 | Pramosone Cream | 57 g in 1 TUBE | CREAM | 57 | | 4 |
| 54766-716-04 | Pramosone Cream | 28.4 g in 1 TUBE | CREAM | 28.4 | | 4 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54766-716 | PRAMOSONE CREAM (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) CREAM [SEBELA PHARMACEUTICALS INC.] | 3 | Current NDC, Legacy NDC, 2 package rows | 20171215_3e8422e0-3bb3-11e5-8cb0-0002a5d5c51b.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 |
|---|
| 54766-716-03 | 54766071603 | 57 g in 1 TUBE (54766-716-03) | 57 g | 2015-08-04 | 2026-07-31 | No | No | Current |
| 54766-716-04 | 54766071604 | 28.4 g in 1 TUBE (54766-716-04) | 28.4 g | 2015-08-04 | 2026-07-31 | No | No | Current |