Prescription drug · ANDA
Analpram HC NDC 54766-829
hydrocortisone acetate and pramoxine hydrochloride · Hydrocortisone acetate 25 mg/mL; Pramoxine hydrochloride 10 mg/mL · Lotion · Topical · Sebela Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 54766-829-04 | 54766082904 | 59 mL in 1 BOTTLE, PLASTIC (54766-829-04)Marketed from Aug 5, 2015 |
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)
- Analpram HC
- Generic name (nonproprietary)
- hydrocortisone acetate and pramoxine hydrochloride
- Active ingredients
- Hydrocortisone acetate — 25 mg/mLPramoxine hydrochloride — 10 mg/mL
- Dosage form
- Lotion
- Route
- Topical
- Labeler
- Sebela Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 085979
- Marketing start
- Marketing end
- Other FDA classes
- Corticosteroid Hormone Receptor Agonists (Mechanism)
- Identifiers
- Product ID 54766-829_431483ef-821d-1ef3-e063-6394a90ad31eSPL ID 431483ef-821d-1ef3-e063-6394a90ad31eSPL set ID 1469733e-1723-4b8c-be33-ed8dfafd65e2RxCUI 1234512, 1360956UNII 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
N454766082904followed by a unit qualifier and the quantityPackage 54766-0829-04. 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.
Other NDCs under ANDA 085979
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 |
|---|---|---|---|---|
| Pramosonehydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 25 mg/mL; Pramoxine hydrochloride 10 mg/mL | LotionTopical | Legacy Pharma USA Inc. | 83107-021 |
| Analpram HChydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 25 mg/g; Pramoxine hydrochloride 10 mg/g | CreamTopical | Legacy Pharma USA Inc. | 83107-019 |
| Analpram HChydrocortisone acetate and pramoxine hydrochloride | Hydrocortisone acetate 25 mg/mL; Pramoxine hydrochloride 10 mg/mL | LotionTopical | Legacy Pharma USA Inc. | 83107-020 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.