Over-the-counter drug · ANDA
Regoxidine (For Men) (minoxidil) NDC 57483-530
Minoxidil 50 mg/g · Aerosol, Foam · Topical · Innovus Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57483-530-31 | 57483053031 | 3 CAN in 1 PACKAGE (57483-530-31) / 60 g in 1 CANMarketed from Nov 12, 2019 |
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 Men)Suffix: (For Men)
- 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 209074
- Marketing start
- Listing expires
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)
- Identifiers
- Product ID 57483-530_36bf641f-2d8d-44ee-a5db-36d1135eebebSPL ID 36bf641f-2d8d-44ee-a5db-36d1135eebebSPL set ID 43b58fd3-81a7-4e64-81f3-9d9acfbf6819RxCUI 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
N457483053031followed by a unit qualifier and the quantityPackage 57483-0530-31. 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 (vertex only, see pictures on side of this carton)
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209074
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 Women)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Innovus Pharmaceuticals, Inc. | 57483-540 |
| Minoxidil (For Women)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | TARGET Corporation | 11673-158 |
| Minoxidil (For Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | CVS Pharmacy | 51316-212 |
| Minoxidil (For Women)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | CVS Pharmacy | 51316-213 |
| Minoxidil (For Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Walgreen Company | 0363-9090 |
| Minoxidil (For Women)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Walgreen Company | 0363-9091 |
| Minoxidil 5% (For Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Sun Pharmaceutical Industries, Inc. | 51672-2128 |
| Minoxidil For Womenminoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Sun Pharmaceutical Industries, Inc. | 51672-2129 |
| Minoxidil (For Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | SPAZI INC. | 82376-6006 |
| Minoxidil (For Women)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | SPAZI INC. | 82376-6007 |
| Minoxidil 5 Percent (For Women)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | PROFECTUS BEAUTY LLC | 70550-605 |
| Gemachlich ZuHause Hair Growth Foam (Men)hair growth foam (men) | Minoxidil 5 g/100mL | LiquidTopical | Guangdong Quadrant Ecological Technology Co., Ltd. | 76986-008 |
| Minoxidil 5% (For Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Thirty MADISON, Inc. | 71713-091 |
| Minoxidil (for Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | RESTORATION HOLDINGS, LLC | 82796-100 |
| Minoxidil (For Women)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Kroger Company | 59450-211 |
| Minoxidil 5% (For Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Kroger Company | 59450-210 |
| Minoxidil (for Women)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Virtue Labs, LLC | 80855-201 |
| Minoxidilminoxidil foam 5% (womens) | Minoxidil 50 mg/g | Aerosol, FoamTopical | Clarity Cosmetics Inc. | 84382-001 |
| Minoxidil (for Women)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | SCIENTIFIC HAIR RESEARCH, LLC | 69113-129 |
| Minoxidil (for Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | SCIENTIFIC HAIR RESEARCH, LLC | 69113-128 |
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