Over-the-counter drug · NDA
Lamisil AT Cream (Terbinafine hydrochloride) NDC 84485-3748
Terbinafine hydrochloride 1 g/100g · Cream · Topical · Karo Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84485-3748-3 | 84485374803 | 1 TUBE in 1 CARTON (84485-3748-3) / 30 g in 1 TUBEMarketed from Nov 1, 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)
- Lamisil AT Cream
- Generic name (nonproprietary)
- terbinafine hydrochloride
- Active ingredients
- Terbinafine hydrochloride — 1 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Karo Healthcare Inc.NDC labeler code 84485
- Product type
- Over-the-counter drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020980
- Marketing start
- Listing expires
- Other FDA classes
- Allylamine (Chemical structure)
- Identifiers
- Product ID 84485-3748_58726dc3-45ee-4543-8863-3949940fb64eSPL ID 58726dc3-45ee-4543-8863-3949940fb64eSPL set ID 7f8434c2-60c9-4aeb-b0b8-f69107e74609RxCUI 992528, 992530UNII 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
N484485374803followed by a unit qualifier and the quantityPackage 84485-3748-03. 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) 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 84485-3748
- What is NDC 84485-3748?
- 84485-3748 is the product NDC for Lamisil AT Cream (terbinafine hydrochloride), Terbinafine hydrochloride 1 g/100g cream, 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 Cream (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 Cream?
- 3 other product NDCs are listed under this name. See all Lamisil AT Cream 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 Cream 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 AT Creamterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Karo Healthcare Inc. | 84485-4030 | 84485-4030-01 |
| Lamisil AT Creamterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Karo Healthcare Inc. | 84485-3607 | 84485-3607-01 |
| Lamisil AT Creamterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Voyant Beauty Inc. | 61047-120 | 61047-0120-03 |
Other NDCs under NDA 020980
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 AT Creamterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Voyant Beauty Inc. | 61047-120 |
| Lamisil AT Creamterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Karo Healthcare Inc. | 84485-3607 |
| Lamisil AT Creamterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Karo Healthcare Inc. | 84485-4030 |
| Lamisil At Terbinafine Hydrochlorideterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Voyant Beauty, Inc. | 61047-139 |