Prescription drug · ANDA
Pramosone Cream NDC 83107-017
hydrocortisone acetate and pramoxine hydrochloride · Hydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/g · Cream · Topical · Legacy Pharma USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 83107-017-01 | 83107001701 | 28.4 g in 1 TUBE (83107-017-01)Marketed from Jun 27, 2025 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Pramosone Cream
- Generic name (nonproprietary)
- hydrocortisone acetate and pramoxine hydrochloride
- Active ingredients
- Hydrocortisone acetate — 10 mg/gPramoxine hydrochloride — 10 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Legacy Pharma USA Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 085368
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 83107-017_38cf2148-3f22-d6dd-e063-6394a90a5dbdSPL ID 38cf2148-3f22-d6dd-e063-6394a90a5dbdSPL set ID 6a9fb75b-a2f7-4eca-8dce-d7eb5c122476RxCUI 1116499, 1234519UNII 3X7931PO74, 88AYB867L5UPC 0383107016021
- Pharmacologic class
- Corticosteroid
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N483107001701followed by a unit qualifier and the quantityPackage 83107-0017-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE: Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 085368
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| hydrocortisone acetate pramoxine hcl | Hydrocortisone acetate 1 g/100g; Pramoxine hydrochloride 1 g/100g | CreamTopical | Bryant Ranch Prepack | 72162-1399 |
| hydrocortisone acetate pramoxine hcl | Hydrocortisone acetate 1 g/100g; Pramoxine hydrochloride 1 g/100g | CreamTopical | Padagis Israel Pharmaceuticals Ltd | 45802-144 |
| hydrocortisone acetate pramoxine hcl | Hydrocortisone acetate 1 g/100g; Pramoxine hydrochloride 1 g/100g | CreamTopical | Bryant Ranch Prepack | 63629-8669 |
| Pramosone Creamhydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/g | CreamTopical | Legacy Pharma USA Inc. | 83107-016 |
| Analpram HChydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/g | CreamTopical | Legacy Pharma USA Inc. | 83107-018 |