Butenafine Hydrochloride
- Product NDC
- 73581-210
- 11-digit product format
- 735810210
- Labeler code
- 73581
- Product ID
- 73581-210_459b7a6e-8c81-2084-e063-6294a90a4083
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Butenafine Hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- YYBA CORP
- Application
- ANDA205181
- Marketing category
- ANDA
- Marketing start
- 2023-10-12
- Substance
- BUTENAFINE HYDROCHLORIDE
- Active strength
- 10 mg/g
- Pharmacologic classes
- Benzylamine Antifungal [EPC], Benzylamines [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Butenafine Hydrochloride
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| BUTENAFINE HYDROCHLORIDE | 10 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R8XA2029ZI |
| Rxcui | 1298448 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 73581-210-02 | Butenafine Hydrochloride | 1 in 1 CARTON | CREAM | 1 | | 4 |
| 73581-210-02 | Butenafine Hydrochloride | 30 g in 1 TUBE | CREAM | 30 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 73581-210 | BUTENAFINE HYDROCHLORIDE CREAM [YYBA CORP] | 2 | Current NDC, 2 package rows | 20241212_e650d8aa-c809-42ee-a1d9-a6321d5364f5.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 73581-210-02 | 73581021002 | 1 TUBE in 1 CARTON (73581-210-02) / 30 g in 1 TUBE | 1 tube | 2023-10-12 | No | No | Current |