terbinafine hydrochloride
- Product NDC
- 82804-220
- 11-digit product format
- 828040220
- Labeler code
- 82804
- Product ID
- 82804-220_839cfff6-fb7f-489f-8cdb-5abda9bffd31
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- terbinafine hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Proficient Rx LP
- Application
- ANDA078163
- Marketing category
- ANDA
- Marketing start
- 2022-01-28
- 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 |
|---|
| 82804-220-30 | 82804022030 | 30 TABLET in 1 BOTTLE, PLASTIC (82804-220-30) | 30 tablet | 2025-04-24 | No | No | Historical |
| 82804-220-42 | 82804022042 | 42 TABLET in 1 BOTTLE, PLASTIC (82804-220-42) | 42 tablet | 2025-09-04 | No | No | Historical |