Terbinafine Hydrochloride
- Product NDC
- 51672-2140
- 11-digit product format
- 516722140
- Labeler code
- 51672
- Product ID
- 51672-2140_38e5619e-f821-ac84-e063-6394a90a8153
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Terbinafine Hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Sun Pharmaceutical Industries, Inc.
- Application
- ANDA077511
- Marketing category
- ANDA
- Marketing start
- 2007-07-02
- Substance
- TERBINAFINE HYDROCHLORIDE
- Active strength
- 1 g/100g
- Pharmacologic classes
- Allylamine Antifungal [EPC], Allylamine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 012C11ZU6G | TERBINAFINE HYDROCHLORIDE | 78628-80-5 | TERBINAFINE HYDROCHLORIDE |
Packages
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 51672-2140-1 | 51672214001 | 1 TUBE in 1 CARTON (51672-2140-1) / 15 g in 1 TUBE | 1 tube | 2019-02-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Terbinafine Hydrochloride | Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc. | 2025-07-01 | HUMAN OTC DRUG LABEL | 4 |