Terbinafine Hydrochloride
- Product NDC
- 70000-0338
- 11-digit product format
- 700000338
- Labeler code
- 70000
- Product ID
- 70000-0338_39854f19-d8c0-6438-e063-6394a90a9422
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Terbinafine Hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- Cardinal Health, 110 dba LEADER
- Application
- ANDA077511
- Marketing category
- ANDA
- Marketing start
- 2018-07-30
- 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 |
|---|
| 70000-0338-1 | Terbinafine Hydrochloride | 1 in 1 CARTON | CREAM | 1 | | 3 |
| 70000-0338-1 | Terbinafine Hydrochloride | 15 g in 1 TUBE | CREAM | 15 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70000-0338 | TERBINAFINE HYDROCHLORIDE CREAM [CARDINAL HEALTH, 110 DBA LEADER] | 2 | Current NDC, Legacy NDC, 2 package rows | 20210622_a9412747-c7f9-4242-91ed-3695f372f6c9.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 |
|---|
| 70000-0338-1 | 70000033801 | 1 TUBE in 1 CARTON (70000-0338-1) / 15 g in 1 TUBE | 1 tube | 2018-07-30 | 0000-00-00 | No | No | Current |