Over-the-counter drug · ANDA
Tomum Hair Growth Treatment For Men Minoxidil Unscented (Minoxidil) NDC 85003-546
Minoxidil 50 mg/mL · Solution · Topical · BELLEKA INC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 85003-546-00 | 8500305460085003054600 | 1 BOTTLE, SPRAY in 1 BOX (85003-546-00) / 60 mL in 1 BOTTLE, SPRAYMarketed from Sep 27, 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)
- Tomum Hair Growth Treatment For Men Minoxidil Unscented
- Generic name (nonproprietary)
- minoxidil
- Active ingredients
- Minoxidil — 50 mg/mL
- Dosage form
- Solution
- Route
- Topical
- Labeler
- BELLEKA INCNDC labeler code 85003
- 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 85003-546_286f1aeb-b73b-9838-e063-6394a90ab231SPL ID 286f1aeb-b73b-9838-e063-6394a90ab231SPL set ID 4c0582a3-f2be-4e53-a174-12269f7ddad0RxCUI 311724UNII 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
N485003054600followed by a unit qualifier and the quantityPackage 85003-0546-00. 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 85003-546
- What is NDC 85003-546?
- 85003-546 is the product NDC for Tomum Hair Growth Treatment For Men Minoxidil Unscented, Minoxidil 50 mg/mL solution, listed with the FDA by BELLEKA INC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Tomum Hair Growth Treatment For Men Minoxidil Unscented (Minoxidil).
- What is the active ingredient?
- Minoxidil.
- Who is the labeler?
- BELLEKA INC, NDC labeler code 85003. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Tomum Hair Growth Treatment For Men 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 076239
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
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