Terbinafine Hydrochloride
- Product NDC
- 68788-9814
- 11-digit product format
- 687889814
- Labeler code
- 68788
- Product ID
- 68788-9814_02fc7642-968f-4ddf-a86a-146ed1a40162
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Terbinafine Hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Preferred Pharmaceuticals, Inc
- Application
- ANDA077511
- Marketing category
- ANDA
- Marketing start
- 2012-04-05
- Substance
- TERBINAFINE HYDROCHLORIDE
- Active strength
- 1 g/100g
- 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 | 1 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 012C11ZU6G |
| Rxcui | 992528 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68788-9814-1 | Terbinafine Hydrochloride | 15 g in 1 TUBE | CREAM | 15 | | 9 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Terbinafine Hydrochloride | ACTIVE INGREDIENT | 012C11ZU6G | TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| Terbinafine | ACTIVE MOIETY | G7RIW8S0XP | TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| benzyl alcohol | INACTIVE INGREDIENT | LKG8494WBH | TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| cetyl alcohol | INACTIVE INGREDIENT | 936JST6JCN | TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| cetyl palmitate | INACTIVE INGREDIENT | 5ZA2S6B08X | TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| isopropyl myristate | INACTIVE INGREDIENT | 0RE8K4LNJS | TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| polysorbate 60 | INACTIVE INGREDIENT | CAL22UVI4M | TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| sorbitan monostearate | INACTIVE INGREDIENT | NVZ4I0H58X | TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| stearyl alcohol | INACTIVE INGREDIENT | 2KR89I4H1Y | TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC] | 1 | |
| water | INACTIVE INGREDIENT | 059QF0KO0R | TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68788-9814 | TERBINAFINE HYDROCHLORIDE CREAM [PREFERRED PHARMACEUTICALS, INC] | 8 | Current NDC, Legacy NDC, 1 package rows | 20240820_6016e546-6c02-4af0-888c-c0899865c5f0.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 |
|---|
| 68788-9814-1 | 68788981401 | 15 g in 1 TUBE (68788-9814-1) | 15 g | 2012-04-05 | 0000-00-00 | No | No | Current |