TERBINAFINE HYDROCHLORIDE
- Product NDC
- 69292-225
- 11-digit product format
- 692920225
- Labeler code
- 69292
- Product ID
- 69292-225_75074aee-6269-496a-99c9-1c0de09f9f50
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbinafine Tablets 250 mg
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Amici Pharma, Inc.
- Application
- ANDA076390
- Marketing category
- ANDA
- Marketing start
- 2026-02-18
- Substance
- TERBINAFINE HYDROCHLORIDE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Allylamine Antifungal [EPC], Allylamine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TERBINAFINE HYDROCHLORIDE
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TERBINAFINE HYDROCHLORIDE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 012C11ZU6G |
| Rxcui | 313222 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69292-225-01 | TERBINAFINE HYDROCHLORIDE | 100 in 1 BOTTLE | TABLET | 100 | | 1 |
| 69292-225-30 | TERBINAFINE HYDROCHLORIDE | 30 in 1 BOTTLE | TABLET | 30 | | 1 |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 69292-225-01 | 69292022501 | 100 TABLET in 1 BOTTLE (69292-225-01) | 100 tablet | 2026-02-18 | No | No | Current |
| 69292-225-30 | 69292022530 | 30 TABLET in 1 BOTTLE (69292-225-30) | 30 tablet | 2026-02-18 | No | No | Current |