Over-the-counter drug · NDA
Lamisil AT (Terbinafine hydrochloride) NDC 84485-3605
Terbinafine hydrochloride 1 g/100g · Spray · Topical · Karo Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84485-3605-4 | 84485360504 | 120 g in 1 CAN (84485-3605-4)Marketed from Dec 10, 2025 |
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)
- Lamisil AT
- Generic name (nonproprietary)
- terbinafine hydrochloride
- Active ingredients
- Terbinafine hydrochloride — 1 g/100g
- Dosage form
- Spray
- Route
- Topical
- Labeler
- Karo Healthcare Inc.NDC labeler code 84485
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021124
- Marketing start
- Listing expires
- Other FDA classes
- Allylamine (Chemical structure)
- Identifiers
- Product ID 84485-3605_21f1bf77-4338-4b75-b513-80a0d98a722aSPL ID 21f1bf77-4338-4b75-b513-80a0d98a722aSPL set ID 21f1bf77-4338-4b75-b513-80a0d98a722aRxCUI 992535, 992536UNII 012C11ZU6G
- Pharmacologic class
- Allylamine 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
N484485360504followed by a unit qualifier and the quantityPackage 84485-3605-04. 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 athlete’s foot (tinea pedis) between the toes. Effectiveness on the bottom or sides of foot is unknown. • cures most jock itch (tinea cruris) and ringworm (tinea corporis) • relieves itching, burning, cracking and scaling which accompany these conditions
Excerpt only. Read the full label for complete information.
About NDC 84485-3605
- What is NDC 84485-3605?
- 84485-3605 is the product NDC for Lamisil AT (terbinafine hydrochloride), Terbinafine hydrochloride 1 g/100g spray, listed with the FDA by Karo Healthcare Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lamisil AT (Terbinafine hydrochloride).
- What is the active ingredient?
- Terbinafine hydrochloride.
- Who is the labeler?
- Karo Healthcare Inc., NDC labeler code 84485. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lamisil AT?
- 1 other product NDC are listed under this name. See all Lamisil AT NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lamisil AT products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lamisil ATterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | SprayTopical | Karo Healthcare Inc. | 84485-3606 | 84485-3606-04 |
Other NDCs under NDA 021124
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 |
|---|---|---|---|---|
| Lamisil ATterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | SprayTopical | Karo Healthcare Inc. | 84485-3606 |