Terbinafine Hydrochloride
- Product NDC
- 50090-1048
- 11-digit product format
- 500901048
- Labeler code
- 50090
- Product ID
- 50090-1048_1d9dab8d-1e3b-4c35-847d-57dbaa8c2ead
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbinafine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA077714
- Marketing category
- ANDA
- Marketing start
- 2010-12-27
- Substance
- TERBINAFINE HYDROCHLORIDE
- Active strength
- 250 mg/1
- 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 |
|---|
| 50090-1048-0 | 50090104800 | 30 TABLET in 1 BOTTLE (50090-1048-0) | 30 tablet | 2014-11-28 | No | No | Historical |
| 50090-1048-1 | 50090104801 | 90 TABLET in 1 BOTTLE (50090-1048-1) | 90 tablet | 2014-11-28 | No | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Terbinafine Hydrochloride | A-S Medication Solutions | 2023-10-31 | HUMAN PRESCRIPTION DRUG LABEL | 15 |