pramosone
- Product NDC
- 83107-015
- 11-digit product format
- 831070015
- Labeler code
- 83107
- Product ID
- 83107-015_4d4fc681-e948-f9f1-e063-6294a90a673f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- hydrocortisone acetate and pramoxine hydrochloride
- Dosage form
- OINTMENT
- Route
- TOPICAL
- Labeler
- Legacy Pharma USA Inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2026-03-18
- 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
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
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 Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83107-015-01 | pramosone | 28.4 g in 1 TUBE | OINTMENT | 28.4 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 83107-015-01 | 83107001501 | 28.4 g in 1 TUBE (83107-015-01) | 28.4 g | 2026-03-18 | No | No | Historical |