Prescription drug · ANDA
hydrocortisone acetate pramoxine hcl NDC 72162-1399
Hydrocortisone acetate 1 g/100g; Pramoxine hydrochloride 1 g/100g · Cream · Topical · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-1399-3 | 72162139903 | 1 TUBE in 1 CARTON (72162-1399-3) / 28.35 g in 1 TUBEMarketed from Aug 17, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- hydrocortisone acetate pramoxine hcl
- Generic name (nonproprietary)
- hydrocortisone acetate pramoxine hcl
- Active ingredients
- Hydrocortisone acetate — 1 g/100gPramoxine hydrochloride — 1 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Bryant Ranch Prepack
- 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 72162-1399_a2e2f237-1138-464a-9c64-e0e42a15bf1eSPL ID a2e2f237-1138-464a-9c64-e0e42a15bf1eSPL set ID 0c28458a-cc56-4eea-89aa-d60659bd9568RxCUI 1235049UNII 3X7931PO74, 88AYB867L5
- 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
N472162139903followed by a unit qualifier and the quantityPackage 72162-1399-03. 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 | 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. | 83107-017 |
| 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 |