Pramosone
- Product NDC
- 54766-777
- 11-digit product format
- 547660777
- Labeler code
- 54766
- Product ID
- 54766-777_6063ad02-65bd-4b2e-e053-2991aa0af3d4
- 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
- 25 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 | 25 mg/g |
| PRAMOXINE HYDROCHLORIDE | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3X7931PO74, 88AYB867L5 |
| Rxcui | 1234333, 1234338 |
DailyMed Product Concepts#
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 54766-777 | PRAMOSONE (HYDROCORTISONE ACETATE AND PRAMOXINE HYDROCHLORIDE) OINTMENT [SEBELA PHARMACEUTICALS INC.] | 3 | Legacy NDC | 20171215_b955de80-3bb5-11e5-ac7f-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 |
|---|
| 54766-777-04 | 54766077704 | 28.4 g in 1 TUBE (54766-777-04) | 28.4 g | 2015-08-05 | 0000-00-00 | No | No | Current |