NDC codes

FDA NDC Directory
Product NDC (as listed)72162-1399Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72162-1399Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
72162-1399-3721621399031 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
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

N472162139903 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 085368

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 085368
ProductStrengthForm · routeLabelerProduct NDC
hydrocortisone acetate pramoxine hclHydrocortisone acetate 1 g/100g; Pramoxine hydrochloride 1 g/100gCreamTopicalPadagis Israel Pharmaceuticals Ltd45802-144
hydrocortisone acetate pramoxine hclHydrocortisone acetate 1 g/100g; Pramoxine hydrochloride 1 g/100gCreamTopicalBryant Ranch Prepack63629-8669
Pramosone Creamhydrocortisone acetate and pramoxine hydrochlorideHydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/gCreamTopicalLegacy Pharma USA Inc.83107-017
Pramosone Creamhydrocortisone acetate and pramoxine hydrochlorideHydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/gCreamTopicalLegacy Pharma USA Inc.83107-016
Analpram HChydrocortisone acetate and pramoxine hydrochlorideHydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/gCreamTopicalLegacy Pharma USA Inc.83107-018

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