Over-the-counter drug · ANDA
Elevate Hair Regrowth Treatment 5 Minoxidil Solution (Minoxidil) NDC 84561-514
Minoxidil 50 mg/mL · Solution · Topical · VAPOR PRO SHOPPE, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84561-514-00 | 8456105140084561051400 | 1 BOTTLE, DROPPER in 1 BOX (84561-514-00) / 60 mL in 1 BOTTLE, DROPPERMarketed from Jul 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)
- Elevate Hair Regrowth Treatment 5 Minoxidil Solution
- Generic name (nonproprietary)
- minoxidil
- Active ingredients
- Minoxidil — 50 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- VAPOR PRO SHOPPE, LLCNDC labeler code 84561
- 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 84561-514_1dd4240e-bb41-0d06-e063-6394a90a36d5SPL ID 1dd4240e-bb41-0d06-e063-6394a90a36d5SPL set ID 12737299-1052-4c93-afab-20016b9d9001RxCUI 311724UNII 5965120SH1UPC 0049022260924
- 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
N484561051400followed by a unit qualifier and the quantityPackage 84561-0514-00. 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 the side of carton)
Excerpt only. Read the full label for complete information.
About NDC 84561-514
- What is NDC 84561-514?
- 84561-514 is the product NDC for Elevate Hair Regrowth Treatment 5 Minoxidil Solution, Minoxidil 50 mg/mL solution, listed with the FDA by VAPOR PRO SHOPPE, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Elevate Hair Regrowth Treatment 5 Minoxidil Solution (Minoxidil).
- What is the active ingredient?
- Minoxidil.
- Who is the labeler?
- VAPOR PRO SHOPPE, LLC, NDC labeler code 84561. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Elevate Hair Regrowth Treatment 5 Minoxidil Solution?
- 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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