Over-the-counter drug · ANDA
Womens Minoxidil Hair Growth System (Minoxidil) NDC 51326-161
Minoxidil 20 mg/mL · Liquid · Topical · Topiderm, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51326-161-01 | 5132601610151326016101 | 60 mL in 1 BOTTLE (51326-161-01)Marketed from Mar 26, 2021 |
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)
- Womens Minoxidil Hair Growth SystemSuffix: Hair Growth System
- Generic name (nonproprietary)
- minoxidil
- Active ingredients
- Minoxidil — 20 mg/mL
- Dosage form
- Liquid
- Route
- Topical
- Labeler
- Topiderm, Inc.NDC labeler code 51326
- 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 51326-161_b2a7381d-b3ed-4db7-b7eb-06a3894ae34bSPL ID b2a7381d-b3ed-4db7-b7eb-06a3894ae34bSPL set ID 6cd3532a-1c1d-44bb-9f7e-c9dc085e2f96RxCUI 311723UNII 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
N451326016101followed by a unit qualifier and the quantityPackage 51326-0161-01. 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 51326-161
- What is NDC 51326-161?
- 51326-161 is the product NDC for Womens Minoxidil Hair Growth System, Minoxidil 20 mg/mL liquid, listed with the FDA by Topiderm, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Womens Minoxidil Hair Growth System (Minoxidil).
- What is the active ingredient?
- Minoxidil.
- Who is the labeler?
- Topiderm, Inc., NDC labeler code 51326. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Womens Minoxidil Hair Growth System?
- 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.