Over-the-counter drug · NDA
Lotrimin Ultra Ringworm (butenafine hydrochloride) NDC 11523-0158
Butenafine hydrochloride 1 g/100g · Cream · Topical · Bayer Healthcare LLC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 11523-0158-2 | 11523015802 | 1 TUBE in 1 CARTON (11523-0158-2) / 30 g in 1 TUBEMarketed from Jul 31, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Lotrimin Ultra RingwormSuffix: Ringworm
- Generic name (nonproprietary)
- butenafine hydrochloride
- Active ingredients
- Butenafine hydrochloride — 1 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Bayer Healthcare LLC.
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021307
- Marketing start
- Listing expires
- Other FDA classes
- Benzylamines (Chemical structure)
- Identifiers
- Product ID 11523-0158_4526df19-7a72-0f19-e063-6394a90a3954SPL ID 4526df19-7a72-0f19-e063-6394a90a3954SPL set ID 1b438ca7-fd5f-62cb-e063-6294a90ab3a6RxCUI 1298448UNII R8XA2029ZI
- Pharmacologic class
- Benzylamine Antifungal
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
N411523015802followed by a unit qualifier and the quantityPackage 11523-0158-02. 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)
Uses cures most ringworm cures most jock itch cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. relieves itching, burning, cracking, and scaling which accompany these conditions
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021307
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Lotrimin Ultra Athletes Footbutenafine hydrochloride | Butenafine hydrochloride 1 g/100g | CreamTopical | Bayer Healthcare LLC. | 11523-4338 |
| Lotrimin Ultra Jock Itchbutenafine hydrochloride | Butenafine hydrochloride 1 g/100g | CreamTopical | Bayer Healthcare LLC. | 11523-4339 |
| Lotrimin Ultrabutenafine hydrochloride | Butenafine hydrochloride 1 g/100g | CreamTopical | Bayer Healthcare LLC. | 11523-0082 |