Prescription drug · NDA
Rhofade (Oxymetazoline hydrochloride) NDC 51862-765
Oxymetazoline hydrochloride 10 mg/g · Cream · Topical · Mayne Pharma
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51862-765-00 | 5186207650051862076500 | 15 TUBE in 1 CARTON (51862-765-00) / 3 g in 1 TUBEMarketed from Jul 11, 2025 | |
| 51862-765-30 | 5186207653051862076530 | 1 TUBE in 1 CARTON (51862-765-30) / 30 g in 1 TUBEMarketed from Oct 24, 2024 |
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)
- Rhofade
- Generic name (nonproprietary)
- oxymetazoline hydrochloride
- Active ingredients
- Oxymetazoline hydrochloride — 10 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Mayne PharmaNDC labeler code 51862
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208552
- Marketing start
- Listing expires
- Other FDA classes
- Imidazolines (Chemical structure)Increased Sympathetic Activity (Physiologic effect)Vasoconstriction (Physiologic effect)
- Identifiers
- Product ID 51862-765_1314d411-e0a5-402b-89ff-49847937838dSPL ID 1314d411-e0a5-402b-89ff-49847937838dSPL set ID f7dbf12e-a802-4261-bae2-c20977698933RxCUI 1869816, 1869821UNII K89MJ0S5VY
- Pharmacologic class
- Vasoconstrictor
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
N451862076500followed by a unit qualifier and the quantityPackage 51862-0765-00. 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)
RHOFADE ® (oxymetazoline hydrochloride) cream, 1% is indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. Rhofade cream is an alpha 1A adrenoceptor agonist indicated for the topical treatment of persistent facial erythema associated with rosacea in adults. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 51862-765
- What is NDC 51862-765?
- 51862-765 is the product NDC for Rhofade (oxymetazoline hydrochloride), Oxymetazoline hydrochloride 10 mg/g cream, listed with the FDA by Mayne Pharma. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rhofade (Oxymetazoline hydrochloride).
- What is the active ingredient?
- Oxymetazoline hydrochloride.
- Who is the labeler?
- Mayne Pharma, NDC labeler code 51862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rhofade?
- 2 other product NDCs are listed under this name. See all Rhofade NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rhofade products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rhofadeoxymetazoline hydrochloride | Oxymetazoline hydrochloride 10 mg/g | CreamTopical | Mayne Pharma | 68308-766 | 68308-0766-30 |
| Rhofadeoxymetazoline hydrochloride | Oxymetazoline hydrochloride 1 g/100g | CreamTopical | EPI Health, LLC | 71403-003 | 71403-0003-1571403-0003-30 |
Other NDCs under NDA 208552
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 |
|---|---|---|---|---|
| Rhofadeoxymetazoline hydrochloride | Oxymetazoline hydrochloride 10 mg/g | CreamTopical | Mayne Pharma | 68308-766 |
| Rhofadeoxymetazoline hydrochloride | Oxymetazoline hydrochloride 1 g/100g | CreamTopical | EPI Health, LLC | 71403-003 |