Prescription drug · UNAPPROVED DRUG OTHER
Pramosone NDC 54766-777
hydrocortisone acetate and pramoxine hydrochloride · Hydrocortisone acetate 25 mg/g; Pramoxine hydrochloride 10 mg/g · Ointment · Topical · Sebela Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54766-777-04 | 5476607770454766077704 | 28.4 g in 1 TUBE (54766-777-04)Marketed from May 26, 2026 |
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
- Generic name (nonproprietary)
- hydrocortisone acetate and pramoxine hydrochloride
- Active ingredients
- Hydrocortisone acetate — 25 mg/gPramoxine hydrochloride — 10 mg/g
- Dosage form
- Ointment
- Route
- Topical
- Labeler
- Sebela Pharmaceuticals Inc.NDC labeler code 54766
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 54766-777_52fa7b5f-1e33-3070-e063-6394a90afc13SPL ID 52fa7b5f-1e33-3070-e063-6394a90afc13SPL set ID b955de80-3bb5-11e5-ac7f-0002a5d5c51bRxCUI 1234333, 1234338UNII 3X7931PO74, 88AYB867L5UPC 0354766777042
- 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
N454766077704followed by a unit qualifier and the quantityPackage 54766-0777-04. 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.
About NDC 54766-777
- What is NDC 54766-777?
- 54766-777 is the product NDC for Pramosone, Hydrocortisone acetate 25 mg/g; Pramoxine hydrochloride 10 mg/g ointment, listed with the FDA by Sebela Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pramosone (Hydrocortisone acetate and pramoxine hydrochloride).
- What is the active ingredient?
- Hydrocortisone acetate, Pramoxine hydrochloride.
- Who is the labeler?
- Sebela Pharmaceuticals Inc., NDC labeler code 54766. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pramosone?
- 6 other product NDCs are listed under this name. See all Pramosone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pramosone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pramosonehydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/g | OintmentTopical | Sebela Pharmaceuticals Inc. | 54766-763 | — |
| Pramosonehydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 25 mg/g; Pramoxine hydrochloride 10 mg/g | OintmentTopical | Legacy Pharma USA Inc | 83107-014 | 83107-0014-01 |
| pramosonehydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/g | OintmentTopical | Legacy Pharma USA Inc. | 83107-015 | 83107-0015-01 |
| Pramosonehydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 10 mg/mL; Pramoxine hydrochloride 10 mg/mL | LotionTopical | Legacy Pharma USA Inc. | 83107-022 | 83107-0022-04 |
| Pramosonehydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 25 mg/mL; Pramoxine hydrochloride 10 mg/mL | LotionTopical | Legacy Pharma USA Inc. | 83107-021 | 83107-0021-0283107-0021-04 |
| Pramosonehydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 10 mg/mL; Pramoxine hydrochloride 10 mg/mL | LotionTopical | Sebela Pharmaceuticals Inc. | 54766-729 | 54766-0729-04 |