Over-the-counter drug · ANDA
Stafenit Hair Regrowth Treatment Topical Minoxidil (Minoxidil) NDC 85097-576
Minoxidil 50 mg/mL · Solution · Topical · Cozesmo
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85097-576-00 | 8509705760085097057600 | 1 BOTTLE, DROPPER in 1 BOX (85097-576-00) / 60 mL in 1 BOTTLE, DROPPERMarketed from Dec 11, 2024 |
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)
- Stafenit Hair Regrowth Treatment Topical Minoxidil
- Generic name (nonproprietary)
- minoxidil
- Active ingredients
- Minoxidil — 50 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- CozesmoNDC labeler code 85097
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076239
- Marketing start
- Listing expires
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)
- Identifiers
- Product ID 85097-576_2b43c093-2e44-fc04-e063-6394a90a1907SPL ID 2b43c093-2e44-fc04-e063-6394a90a1907SPL set ID cd74cc10-6df4-47bf-885e-333244db6d82RxCUI 311724UNII 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
N485097057600followed by a unit qualifier and the quantityPackage 85097-0576-00. 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 picture on side of carton)
Excerpt only. Read the full label for complete information.
About NDC 85097-576
- What is NDC 85097-576?
- 85097-576 is the product NDC for Stafenit Hair Regrowth Treatment Topical Minoxidil, Minoxidil 50 mg/mL solution, listed with the FDA by Cozesmo. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Stafenit Hair Regrowth Treatment Topical Minoxidil (Minoxidil).
- What is the active ingredient?
- Minoxidil.
- Who is the labeler?
- Cozesmo, NDC labeler code 85097. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Stafenit Hair Regrowth Treatment Topical Minoxidil?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under ANDA 076239
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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