pramosone
- Product NDC
- 54766-763
- 11-digit product format
- 547660763
- Labeler code
- 54766
- Product ID
- 54766-763_6063a847-17e1-7fa2-e053-2a91aa0abccc
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocortisone acetate and pramoxine hydrochloride
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Sebela Pharmaceuticals Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2015-08-05
- Marketing end
- 0000-00-00
- Substance
- HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
- Active strength
- 10 mg/g; mg/g
- Pharmacologic classes
- Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pramosone
- Listing expiration
- 2027-12-31
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 | 1234317, 1234322 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54766-763 | PRAMOSONE (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SEBELA PHARMACEUTICALS INC.] | 4 | Legacy NDC | 20241114_d4d85400-3bb3-11e5-830e-0002a5d5c51b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 54766-763-04 | 54766076304 | 28.4 g in 1 TUBE (54766-763-04) | 28.4 g | 2015-08-05 | 0000-00-00 | No | No | Current |