Over-the-counter drug · ANDA
Regoxidine (For Women) (Minoxidil) NDC 57483-540
Minoxidil 50 mg/g · Aerosol, Foam · Topical · Innovus Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 57483-540-31 | 5748305403157483054031 | 2 CAN in 1 PACKAGE (57483-540-31) / 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 Women)Suffix: (For Women)
- Generic name (nonproprietary)
- minoxidil
- Active ingredients
- Minoxidil — 50 mg/g
- Dosage form
- Aerosol, Foam
- Route
- Topical
- Labeler
- Innovus Pharmaceuticals, Inc.NDC labeler code 57483
- 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 57483-540_61359d4f-de10-41f1-a795-f2ae3bda5b1dSPL ID 61359d4f-de10-41f1-a795-f2ae3bda5b1dSPL set ID b60cc177-700c-4007-be1a-2cb74824e657RxCUI 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
N457483054031followed by a unit qualifier and the quantityPackage 57483-0540-31. 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 (see pictures on side of this carton)
Excerpt only. Read the full label for complete information.
About NDC 57483-540
- What is NDC 57483-540?
- 57483-540 is the product NDC for Regoxidine (For Women) (minoxidil), Minoxidil 50 mg/g aerosol, foam, listed with the FDA by Innovus Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Regoxidine (For Women) (Minoxidil).
- What is the active ingredient?
- Minoxidil.
- Who is the labeler?
- Innovus Pharmaceuticals, Inc., NDC labeler code 57483. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Regoxidine (For Women)?
- 1 other product NDC are listed under this name. See all Regoxidine (For Women) NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Regoxidine (For Women) products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Regoxidine (For Women)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | INNOVUS PHARMACEUTICALS, INC. | 57483-175 | 57483-0175-1157483-0175-12 |
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 |
|---|---|---|---|---|
| Gemachlich ZuHause Hair Growth Foam (Men)hair growth foam (men) | Minoxidil 5 g/100mL | LiquidTopical | Guangdong Quadrant Ecological Technology Co., Ltd. | 76986-008 |
| Minoxidilminoxidil foam 5% (womens) | Minoxidil 50 mg/g | Aerosol, FoamTopical | Clarity Cosmetics Inc. | 84382-001 |
| Minoxidil (For Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Walgreen Company | 0363-9090 |
| Minoxidil (For Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | TARGET Corporation | 11673-157 |
| Minoxidil (For Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | CVS Pharmacy | 51316-212 |
| Minoxidil (for Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | SCIENTIFIC HAIR RESEARCH, LLC | 69113-128 |
| Minoxidil (For Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | SPAZI INC. | 82376-6006 |
| 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 | Walgreen Company | 0363-9091 |
| Minoxidil (For Women)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | TARGET Corporation | 11673-158 |
| Minoxidil (For Women)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | CVS Pharmacy | 51316-213 |
| Minoxidil (For Women)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Kroger Company | 59450-211 |
| Minoxidil (for Women)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | SCIENTIFIC HAIR RESEARCH, LLC | 69113-129 |
| Minoxidil (for Women)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Virtue Labs, LLC | 80855-201 |
| 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 |
| Minoxidil 5% (For Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Sun Pharmaceutical Industries, Inc. | 51672-2128 |
| Minoxidil 5% (For Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Kroger Company | 59450-210 |
| Minoxidil 5% (For Men)minoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Thirty MADISON, Inc. | 71713-091 |
| Minoxidil For Womenminoxidil | Minoxidil 50 mg/g | Aerosol, FoamTopical | Sun Pharmaceutical Industries, Inc. | 51672-2129 |
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