Over-the-counter drug · NDA
Lamisil At Terbinafine Hydrochloride (Terbinafine hydrochloride) NDC 61047-139
Terbinafine hydrochloride 1 g/100g · Cream · Topical · Voyant Beauty, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 61047-139-01 | 61047013901 | 1 TUBE in 1 CARTON (61047-139-01) / 30 g in 1 TUBEMarketed from Aug 21, 2024 | |
| 61047-139-02 | 61047013902 | 1 TUBE in 1 CARTON (61047-139-02) / 12 g in 1 TUBEMarketed from Jan 6, 2025 |
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)
- Lamisil At Terbinafine Hydrochloride
- Generic name (nonproprietary)
- terbinafine hydrochloride
- Active ingredients
- Terbinafine hydrochloride — 1 g/100g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Voyant Beauty, Inc.NDC labeler code 61047
- 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 61047-139_3f018131-adda-6d1b-e063-6394a90a09f5SPL ID 3f018131-adda-6d1b-e063-6394a90a09f5SPL set ID 1fd313ad-a3d9-6c86-e063-6394a90a7ae4RxCUI 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
N461047013901followed by a unit qualifier and the quantityPackage 61047-0139-01. 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)
- cures most athlete's foot (tinea pedis) - cure most jock itch (tinea cruris) and ringworm (tinea corporis) - relieves itching, burning, cracking andf scaling which accompany this condition
Excerpt only. Read the full label for complete information.
About NDC 61047-139
- What is NDC 61047-139?
- 61047-139 is the product NDC for Lamisil At Terbinafine Hydrochloride, Terbinafine hydrochloride 1 g/100g cream, listed with the FDA by Voyant Beauty, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lamisil At Terbinafine Hydrochloride (Terbinafine hydrochloride).
- What is the active ingredient?
- Terbinafine hydrochloride.
- Who is the labeler?
- Voyant Beauty, Inc., NDC labeler code 61047. 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 Terbinafine Hydrochloride?
- 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 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. | 84485-3748 |
| Lamisil AT Creamterbinafine hydrochloride | Terbinafine hydrochloride 1 g/100g | CreamTopical | Karo Healthcare Inc. | 84485-4030 |