Terbinafine Hydrochloride
- Product NDC
- 72162-1595
- 11-digit product format
- 721621595
- Labeler code
- 72162
- Product ID
- 72162-1595_f9f34f4d-d49d-4921-9e3e-8b6e2fd16d9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbinafine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Bryant Ranch Prepack
- 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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Terbinafine Hydrochloride
- Listing expiration
- 2026-12-31
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 |
|---|
| 72162-1595-1 | Terbinafine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 101 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 72162-1595 | TERBINAFINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 101 | Current NDC, 1 package rows | 20250327_e2ecf7a5-1c84-4977-8a87-d1bfb9658668.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 72162-1595-1 | 72162159501 | 100 TABLET in 1 BOTTLE (72162-1595-1) | 100 tablet | 2024-02-07 | No | No | Current |