Over-the-counter drug · ANDA
Santo Remedio Womens Hair Regrowth Treatment Minoxidil Unscented (Minoxidil) NDC 81352-561
Minoxidil 20 mg/mL · Solution · Topical · SANTO REMEDIO LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81352-561-00 | 8135205610081352056100 | 1 BOTTLE, DROPPER in 1 BOX (81352-561-00) / 60 mL in 1 BOTTLE, DROPPERMarketed from Nov 8, 2024 | |
| 81352-561-03 | 8135205610381352056103 | 3 BOTTLE, DROPPER in 1 BOX (81352-561-03) / 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 Womens Hair Regrowth Treatment Minoxidil Unscented
- Generic name (nonproprietary)
- minoxidil
- Active ingredients
- Minoxidil — 20 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 81352-561_29955a9c-7338-cc67-e063-6394a90a96e1SPL ID 29955a9c-7338-cc67-e063-6394a90a96e1SPL set ID cfc7adf1-627b-41e1-b51a-cdcd8a14e796RxCUI 311723UNII 5965120SH1UPC 0810047701491, 0810047701507
- 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
N481352056100followed by a unit qualifier and the quantityPackage 81352-0561-00. 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 scalp
Excerpt only. Read the full label for complete information.
About NDC 81352-561
- What is NDC 81352-561?
- 81352-561 is the product NDC for Santo Remedio Womens Hair Regrowth Treatment Minoxidil Unscented, Minoxidil 20 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 Womens Hair Regrowth Treatment Minoxidil 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 Womens Hair Regrowth Treatment Minoxidil 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.