What is NDC 83107-016?

83107-016 is the product NDC for Pramosone Cream, Hydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/g cream, listed with the FDA by Legacy Pharma USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Pramosone Cream (Hydrocortisone acetate and pramoxine hydrochloride).

What is the active ingredient?

Hydrocortisone acetate, Pramoxine hydrochloride.

Legacy Pharma USA Inc., NDC labeler code 83107. 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 Cream?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Pramosone Cream NDC 83107-016 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)83107-016Labeler and product segments. Claims need a package NDC.

Product NDC at billing width83107-0016Add 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
83107-016-02	8310700160283107001602	57 g in 1 TUBE (83107-016-02)Marketed from Jun 27, 2025

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 Cream
Generic name (nonproprietary): hydrocortisone acetate and pramoxine hydrochloride
Active ingredients: Hydrocortisone acetate — 10 mg/gPramoxine hydrochloride — 10 mg/g
Dosage form: Cream
Route: Topical
Labeler: Legacy Pharma USA Inc.NDC labeler code 83107
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 085368
Marketing start: Jun 27, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Corticosteroid Hormone Receptor Agonists (Mechanism)
Identifiers: Product ID 83107-016_38cf2148-3f22-d6dd-e063-6394a90a5dbdSPL ID 38cf2148-3f22-d6dd-e063-6394a90a5dbdSPL set ID 6a9fb75b-a2f7-4eca-8dce-d7eb5c122476RxCUI 1116499, 1234519UNII 88AYB867L5, 3X7931PO74UPC 0383107016021
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

N483107001602 followed by a unit qualifier and the quantity

Package 83107-0016-02. 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 Jun 30, 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)

About NDC 83107-016

What is NDC 83107-016?: 83107-016 is the product NDC for Pramosone Cream, Hydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/g cream, listed with the FDA by Legacy Pharma USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Pramosone Cream (Hydrocortisone acetate and pramoxine hydrochloride).
What is the active ingredient?: Hydrocortisone acetate, Pramoxine hydrochloride.
Who is the labeler?: Legacy Pharma USA Inc., NDC labeler code 83107. 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 Cream?: 1 other product NDC are listed under this name. See all Pramosone Cream NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Pramosone Cream NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Pramosone Creamhydrocortisone acetate and pramoxine hydrochloride	Hydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/g	CreamTopical	Legacy Pharma USA Inc.	83107-017	83107-0017-01

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
Product	Strength	Form · route	Labeler	Product NDC
Analpram HChydrocortisone acetate and pramoxine hydrochloride	Hydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/g	CreamTopical	Legacy Pharma USA Inc.	83107-018
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
hydrocortisone acetate pramoxine hcl	Hydrocortisone acetate 1 g/100g; Pramoxine hydrochloride 1 g/100g	CreamTopical	Bryant Ranch Prepack	72162-1399
Pramosone Creamhydrocortisone acetate and pramoxine hydrochloride	Hydrocortisone acetate 10 mg/g; Pramoxine hydrochloride 10 mg/g	CreamTopical	Legacy Pharma USA Inc.	83107-017