Prescription drug · NDA
Rhofade (Oxymetazoline hydrochloride) NDC 71403-003
Oxymetazoline hydrochloride 1 g/100g · Cream · Topical · EPI Health, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71403-003-15 | 71403000315 | 1 TUBE in 1 CARTON (71403-003-15) / 3 g in 1 TUBEMarketed from Jan 18, 2021 | |
| 71403-003-30 | 71403000330 | 1 TUBE in 1 CARTON (71403-003-30) / 30 g in 1 TUBEMarketed from Jan 18, 2021 |
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 — 1 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- EPI Health, LLCNDC labeler code 71403
- 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 71403-003_d743c06d-1277-4504-803b-5752af09ba03SPL ID d743c06d-1277-4504-803b-5752af09ba03SPL set ID e82b5788-a855-4165-a81f-7f15cb874612RxCUI 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
N471403000315followed by a unit qualifier and the quantityPackage 71403-0003-15. 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 71403-003
- What is NDC 71403-003?
- 71403-003 is the product NDC for Rhofade (oxymetazoline hydrochloride), Oxymetazoline hydrochloride 1 g/100g cream, listed with the FDA by EPI Health, LLC. 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?
- EPI Health, LLC, NDC labeler code 71403. 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 10 mg/g | CreamTopical | Mayne Pharma | 51862-765 | 51862-0765-0051862-0765-30 |
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 | 51862-765 |
| Rhofadeoxymetazoline hydrochloride | Oxymetazoline hydrochloride 10 mg/g | CreamTopical | Mayne Pharma | 68308-766 |