Pramosone NDC 54766-729

NDC codes

FDA NDC Directory

Product NDC (as listed)54766-729Labeler and product segments. Claims need a package NDC.

Product NDC at billing width54766-0729Add 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 NDC	11-digit (billing)	Package	Copy
54766-729-04	54766072904	118 mL in 1 BOTTLE (54766-729-04)Marketed from Jul 2, 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): Pramosone
Generic name (nonproprietary): hydrocortisone acetate and pramoxine hydrochloride
Active ingredients: Hydrocortisone acetate — 10 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 085980
Marketing start: Jul 2, 2015
Marketing end: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 54766-729_4314aef2-c610-9ee4-e063-6394a90ae0caSPL ID 4314aef2-c610-9ee4-e063-6394a90ae0caSPL set ID f207bdff-2f41-4eee-818e-198b6462863eRxCUI 1234393, 1234396UNII 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

N454766072904 followed by a unit qualifier and the quantity

Package 54766-0729-04. 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 Nov 8, 2025.

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 085980

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

FDA NDC Directory listings under ANDA 085980
Product	Strength	Form · route	Labeler	Product NDC
Pramosonehydrocortisone acetate and pramoxine hydrochloride	Hydrocortisone acetate 10 mg/mL; Pramoxine hydrochloride 10 mg/mL	LotionTopical	Legacy Pharma USA Inc.	83107-022