Over-the-counter drug · ANDA
Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented (Minoxidil) NDC 81352-560
Minoxidil 50 mg/mL · Solution · Topical · SANTO REMEDIO LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81352-560-00 | 8135205600081352056000 | 1 BOTTLE, DROPPER in 1 BOX (81352-560-00) / 60 mL in 1 BOTTLE, DROPPERMarketed from Nov 8, 2024 | |
| 81352-560-03 | 8135205600381352056003 | 3 BOTTLE, DROPPER in 1 BOX (81352-560-03) / 60 mL in 1 BOTTLE, DROPPERMarketed from Nov 8, 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)
- Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented
- Generic name (nonproprietary)
- minoxidil
- Active ingredients
- Minoxidil — 50 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- SANTO REMEDIO LLCNDC labeler code 81352
- Product type
- Over-the-counter drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078176
- Marketing start
- Listing expires
- Other FDA classes
- Arteriolar Vasodilation (Physiologic effect)
- Identifiers
- Product ID 81352-560_2a2d74a0-c971-eeb1-e063-6394a90a9acdSPL ID 2a2d74a0-c971-eeb1-e063-6394a90a9acdSPL set ID 2a2d814f-d716-6e60-e063-6294a90aeb97RxCUI 311724UNII 5965120SH1UPC 0810047701514, 0810047701521
- 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
N481352056000followed by a unit qualifier and the quantityPackage 81352-0560-00. 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 81352-560
- What is NDC 81352-560?
- 81352-560 is the product NDC for Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented, Minoxidil 50 mg/mL solution, listed with the FDA by SANTO REMEDIO LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented (Minoxidil).
- What is the active ingredient?
- Minoxidil.
- Who is the labeler?
- SANTO REMEDIO LLC, NDC labeler code 81352. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Santo Remedio Mens Hair Regrowth Treatment Minoxidil Topical Solution Extra Strength Unscented?
- 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 078176
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.