Over-the-counter drug · ANDA
KERANIQUE Hair Regrowth Treatment For Women (Minoxidil) NDC 70550-578
Minoxidil 20 mg/mL · Spray · Topical · PROFECTUS BEAUTY, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70550-578-01 | 7055005780170550057801 | 1 BOTTLE, SPRAY in 1 BOX (70550-578-01) / 60 mL in 1 BOTTLE, SPRAYMarketed from Jul 17, 2024 | |
| 70550-578-02 | 7055005780270550057802 | 2 BOTTLE, SPRAY in 1 BOX (70550-578-02) / 60 mL in 1 BOTTLE, SPRAYMarketed from Jul 17, 2024 | |
| 70550-578-03 | 7055005780370550057803 | 3 BOTTLE, SPRAY in 1 BOX (70550-578-03) / 60 mL in 1 BOTTLE, SPRAYMarketed from Jul 17, 2024 | |
| 70550-578-04 | 7055005780470550057804 | 4 BOTTLE, SPRAY in 1 BOX (70550-578-04) / 60 mL in 1 BOTTLE, SPRAYMarketed from Jul 17, 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)
- KERANIQUE Hair Regrowth Treatment For Women
- Generic name (nonproprietary)
- minoxidil
- Active ingredients
- Minoxidil — 20 mg/mL
- Dosage form
- Spray
- Route
- Topical
- Labeler
- PROFECTUS BEAUTY, LLCNDC labeler code 70550
- 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 70550-578_2046653c-a5e8-c010-e063-6294a90ae442SPL ID 2046653c-a5e8-c010-e063-6294a90ae442SPL set ID 8d580c01-a13d-81f8-e053-2a95a90a7426RxCUI 1537947UNII 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
N470550057801followed by a unit qualifier and the quantityPackage 70550-0578-01. 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 70550-578
- What is NDC 70550-578?
- 70550-578 is the product NDC for KERANIQUE Hair Regrowth Treatment For Women, Minoxidil 20 mg/mL spray, listed with the FDA by PROFECTUS BEAUTY, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- KERANIQUE Hair Regrowth Treatment For Women (Minoxidil).
- What is the active ingredient?
- Minoxidil.
- Who is the labeler?
- PROFECTUS BEAUTY, LLC, NDC labeler code 70550. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for KERANIQUE Hair Regrowth Treatment For Women?
- 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.