What is NDC 57483-165?

57483-165 is the product NDC for Regoxidine (For Men) (minoxidil), Minoxidil 50 mg/g aerosol, foam, listed with the FDA by INNOVUS PHARMACEUTICALS, INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Regoxidine (For Men) (Minoxidil).

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 Men)?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Regoxidine (For Men) NDC 57483-165

NDC codes

FDA NDC Directory

Product NDC (as listed)57483-165Labeler and product segments. Claims need a package NDC.

Product NDC at billing width57483-0165Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
57483-165-11	5748301651157483016511	1 CAN in 1 CARTON (57483-165-11) / 60 g in 1 CAN (57483-165-01)Marketed from Nov 14, 2025
57483-165-13	5748301651357483016513	3 CAN in 1 CARTON (57483-165-13) / 60 g in 1 CAN (57483-165-01)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 Men)
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 218616
Marketing start: May 3, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Arteriolar Vasodilation (Physiologic effect)
Identifiers: Product ID 57483-165_7f6c711d-2ee7-46d5-8b2c-4cf643bff18eSPL ID 7f6c711d-2ee7-46d5-8b2c-4cf643bff18eSPL set ID d191b3a9-0fb7-45cc-82a1-b64a79c0c125RxCUI 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

N457483016511 followed by a unit qualifier and the quantity

Package 57483-0165-11. 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 Jan 20, 2026.

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.

Full label on DailyMed (opens in a new tab)

About NDC 57483-165

What is NDC 57483-165?: 57483-165 is the product NDC for Regoxidine (For Men) (minoxidil), Minoxidil 50 mg/g aerosol, foam, listed with the FDA by INNOVUS PHARMACEUTICALS, INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Regoxidine (For Men) (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 Men)?: 1 other product NDC are listed under this name. See all Regoxidine (For Men) NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Regoxidine (For Men) NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Regoxidine (For Men)minoxidil	Minoxidil 50 mg/g	Aerosol, FoamTopical	Innovus Pharmaceuticals, Inc.	57483-530	57483-0530-31

Other NDCs under ANDA 218616

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 218616
Product	Strength	Form · route	Labeler	Product NDC
Minoxidil (For Men)minoxidil	Minoxidil 5 g/100g	LiquidTopical	FlexiGo Inc	85524-2611
Minoxidil 5% (For Men)minoxidil	Minoxidil 50 mg/g	Aerosol, FoamTopical	Better Living Brands, LLC	21130-208
Minoxidil 5% (For Men)minoxidil	Minoxidil 50 mg/g	Aerosol, FoamTopical	Aurohealth LLC	58602-608
Minoxidil 5% (For Men)minoxidil	Minoxidil 50 mg/g	Aerosol, FoamTopical	Aurohealth LLC	58602-614
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 For Menminoxidil	Minoxidil 50 mg/g	Aerosol, FoamTopical	CARDINAL HEALTH 110, LLC. DBA LEADER	70000-0754
Minoxidil For Womenminoxidil	Minoxidil 50 mg/g	Aerosol, FoamTopical	CARDINAL HEALTH 110, LLC. DBA LEADER	70000-0753
Nizoral Hair Regrowth Treatment for Menminoxidil	Minoxidil 50 mg/g	Aerosol, FoamTopical	Kramer Laboratories	55505-237
Regoxidine (For Women)minoxidil	Minoxidil 50 mg/g	Aerosol, FoamTopical	INNOVUS PHARMACEUTICALS, INC.	57483-175

Regoxidine (For Men) (Minoxidil) NDC 57483-165

NDC codes

Product information

Billing references

Product label

About NDC 57483-165

Other NDCs under ANDA 218616

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NDC codes

Product information

Billing references

Product label

About NDC 57483-165

Related NDCs: other Regoxidine (For Men) products

Other NDCs under ANDA 218616