Over-the-counter drug · ANDA
Regoxidine (For Women) (minoxidil) NDC 57483-175
Minoxidil 50 mg/g · Aerosol, Foam · Topical · INNOVUS PHARMACEUTICALS, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57483-175-11 | 57483017511 | 1 CAN in 1 CARTON (57483-175-11) / 60 g in 1 CAN (57483-175-01)Marketed from Nov 14, 2025 | |
| 57483-175-12 | 57483017512 | 2 CAN in 1 CARTON (57483-175-12) / 60 g in 1 CAN (57483-175-01)Marketed from May 3, 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)
- Regoxidine (For Women)
- Generic name (nonproprietary)
- minoxidil
- Active ingredients
- Minoxidil — 50 mg/g
- Dosage form
- Aerosol, Foam
- Route
- Topical
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218616
- Marketing start
- Listing expires
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)
- Identifiers
- Product ID 57483-175_40d86d45-ccc6-4b7e-a152-453469b21379SPL ID 40d86d45-ccc6-4b7e-a152-453469b21379SPL set ID 9c06c34d-5a09-47ed-b969-cc81f4ed61abRxCUI 645146, 2264763UNII 5965120SH1
- Pharmacologic class
- Arteriolar Vasodilator
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
N457483017511followed by a unit qualifier and the quantityPackage 57483-0175-11. 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)
Use to regrow hair on the top of the scalp (see pictures on side of this carton)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 218616
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 |
|---|---|---|---|---|
| Regoxidine (For Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | INNOVUS PHARMACEUTICALS, INC. | 57483-165 |
| Minoxidil 5% (For Women)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Aurohealth LLC | 58602-104 |
| Minoxidil 5% (For Women)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Aurohealth LLC | 58602-607 |
| Minoxidil 5% (For Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Aurohealth LLC | 58602-608 |
| Minoxidil (For Men)minoxidil | Minoxidil 5 g/100g | LiquidTopical | FlexiGo Inc | 85524-2611 |
| Nizoral Hair Regrowth Treatment for Menminoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Kramer Laboratories | 55505-237 |
| Minoxidil 5% (For Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Better Living Brands, LLC | 21130-208 |
| Minoxidil For Womenminoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0753 |
| Minoxidil For Menminoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | CARDINAL HEALTH 110, LLC. DBA LEADER | 70000-0754 |