Terbinafine Hydrochloride
- Product NDC
- 50090-1278
- 11-digit product format
- 500901278
- Labeler code
- 50090
- Product ID
- 50090-1278_d0db1c47-4dfe-443e-a514-09f727fb0b9f
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Terbinafine Hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- A-S Medication Solutions
- Application
- ANDA077511
- Marketing category
- ANDA
- Marketing start
- 2007-07-02
- 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 |
|---|
| 50090-1278-0 | Terbinafine Hydrochloride | 15 g in 1 TUBE | CREAM | 15 | | 14 |
| 50090-1278-0 | Terbinafine Hydrochloride | 1 in 1 CARTON | CREAM | 1 | | 14 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50090-1278 | TERBINAFINE HYDROCHLORIDE CREAM [A-S MEDICATION SOLUTIONS] | 14 | Current NDC, Legacy NDC, 2 package rows | 20231210_ef8370dc-8ca4-411d-87e1-dc6af3191330.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 |
|---|
| 50090-1278-0 | 50090127800 | 1 TUBE in 1 CARTON (50090-1278-0) / 15 g in 1 TUBE | 1 tube | 2014-11-28 | 0000-00-00 | No | No | Current |