Prescription drug · UNAPPROVED DRUG OTHER
Pramosone NDC 54766-763
hydrocortisone acetate and pramoxine hydrochloride · Hydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/g · Ointment · Topical · Sebela Pharmaceuticals Inc.
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Pramosone
- Generic name (nonproprietary)
- hydrocortisone acetate and pramoxine hydrochloride
- Active ingredients
- Hydrocortisone acetate — 10 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 54766-763_52f9fd33-b349-62c7-e063-6294a90ae7abSPL ID 52f9fd33-b349-62c7-e063-6294a90ae7abSPL set ID d4d85400-3bb3-11e5-830e-0002a5d5c51bRxCUI 1234317, 1234322UNII 3X7931PO74, 88AYB867L5UPC 0354766763045
- 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.
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 54766-763
- What is NDC 54766-763?
- 54766-763 is the product NDC for Pramosone, Hydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/g ointment, listed with the FDA by Sebela Pharmaceuticals Inc..
- 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 25 mg/g; Pramoxine hydrochloride 10 mg/g | OintmentTopical | Sebela Pharmaceuticals Inc. | 54766-777 | 54766-0777-04 |
| 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 |