Terbinafine
- Product NDC
- 68788-7450
- 11-digit product format
- 687887450
- Labeler code
- 68788
- Product ID
- 68788-7450_f92d2c6c-a52a-4251-bdfc-4d6f8a668dc7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbinafine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Preferred Pharmaceuticals, Inc.
- Application
- ANDA078297
- Marketing category
- ANDA
- Marketing start
- 2007-07-02
- 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
- 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 |
|---|
| 68788-7450-1 | Terbinafine | 100 in 1 BOTTLE | TABLET | 100 | | 7 |
| 68788-7450-3 | Terbinafine | 30 in 1 BOTTLE | TABLET | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-7450 | TERBINAFINE (TERBINAFINE HYDROCHLORIDE) TABLET [PREFERRED PHARMACEUTICALS, INC.] | 6 | Current NDC, Legacy NDC, 2 package rows | 20240820_085e0809-6b7f-447e-976e-8276c29daad6.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 |
|---|
| 68788-7450-1 | 68788745001 | 100 TABLET in 1 BOTTLE (68788-7450-1) | 100 tablet | 2019-12-27 | 0000-00-00 | No | No | Current |
| 68788-7450-3 | 68788745003 | 30 TABLET in 1 BOTTLE (68788-7450-3) | 30 tablet | 2019-12-27 | 0000-00-00 | No | No | Current |