Terbinafine Hydrochloride
- Product NDC
- 63629-1993
- 11-digit product format
- 636291993
- Labeler code
- 63629
- Product ID
- 63629-1993_2b858a61-405a-4352-9da9-978bb1f5a29a
- 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 |
|---|
| 63629-1993-1 | Terbinafine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 103 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63629-1993 | TERBINAFINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 103 | Current NDC, Legacy NDC, 1 package rows | 20240110_facaea7f-cb4d-410f-85e4-e1ac9ff565ac.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63629-1993-1 | 63629199301 | 100 TABLET in 1 BOTTLE (63629-1993-1) | 100 tablet | 2010-12-27 | 0000-00-00 | No | No | Current |