Terbinafine Hydrochloride
- Product NDC
- 71335-0918
- 11-digit product format
- 713350918
- Labeler code
- 71335
- Product ID
- 71335-0918_cefa9c7f-1185-4cf4-9638-90cca0c11d27
- 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 |
|---|
| 71335-0918-1 | Terbinafine Hydrochloride | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
| 71335-0918-2 | Terbinafine Hydrochloride | 60 in 1 BOTTLE | TABLET | 60 | | 7 |
| 71335-0918-3 | Terbinafine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 7 |
| 71335-0918-4 | Terbinafine Hydrochloride | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
| 71335-0918-5 | Terbinafine Hydrochloride | 7 in 1 BOTTLE | TABLET | 7 | | 7 |
| 71335-0918-6 | Terbinafine Hydrochloride | 40 in 1 BOTTLE | TABLET | 40 | | 7 |
| 71335-0918-7 | Terbinafine Hydrochloride | 45 in 1 BOTTLE | TABLET | 45 | | 7 |
| 71335-0918-8 | Terbinafine Hydrochloride | 14 in 1 BOTTLE | TABLET | 14 | | 7 |
| 71335-0918-9 | Terbinafine Hydrochloride | 28 in 1 BOTTLE | TABLET | 28 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 71335-0918 | TERBINAFINE HYDROCHLORIDE TABLET [BRYANT RANCH PREPACK] | 7 | Current NDC, Legacy NDC, 9 package rows | 20240830_17e976c6-ee44-42c5-987f-5360ee6d7c1e.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 |
|---|
| 71335-0918-1 | 71335091801 | 30 TABLET in 1 BOTTLE (71335-0918-1) | 30 tablet | 2018-07-31 | 0000-00-00 | No | No | Current |
| 71335-0918-2 | 71335091802 | 60 TABLET in 1 BOTTLE (71335-0918-2) | 60 tablet | 2024-05-29 | 0000-00-00 | No | No | Current |
| 71335-0918-3 | 71335091803 | 90 TABLET in 1 BOTTLE (71335-0918-3) | 90 tablet | 2022-07-26 | 0000-00-00 | No | No | Current |
| 71335-0918-4 | 71335091804 | 100 TABLET in 1 BOTTLE (71335-0918-4) | 100 tablet | 2024-05-29 | 0000-00-00 | No | No | Current |
| 71335-0918-5 | 71335091805 | 7 TABLET in 1 BOTTLE (71335-0918-5) | 7 tablet | 2024-05-29 | 0000-00-00 | No | No | Current |
| 71335-0918-6 | 71335091806 | 40 TABLET in 1 BOTTLE (71335-0918-6) | 40 tablet | 2024-05-29 | 0000-00-00 | No | No | Current |
| 71335-0918-7 | 71335091807 | 45 TABLET in 1 BOTTLE (71335-0918-7) | 45 tablet | 2018-08-13 | 0000-00-00 | No | No | Current |
| 71335-0918-8 | 71335091808 | 14 TABLET in 1 BOTTLE (71335-0918-8) | 14 tablet | 2018-09-20 | 0000-00-00 | No | No | Current |
| 71335-0918-9 | 71335091809 | 28 TABLET in 1 BOTTLE (71335-0918-9) | 28 tablet | 2021-12-28 | 0000-00-00 | No | No | Current |