Terbinafine Hydrochloride
- Product NDC
- 0363-4502
- 11-digit product format
- 003634502
- Labeler code
- 0363
- Product ID
- 0363-4502_3996583d-a3da-fa4a-e063-6394a90af78a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Terbinafine Hydrochloride
- Dosage form
- CREAM
- Route
- TOPICAL
- Labeler
- WALGREEN COMPANY
- Application
- ANDA077511
- Marketing category
- ANDA
- Marketing start
- 2023-10-25
- 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 |
|---|
| 0363-4502-02 | Terbinafine Hydrochloride | 1 in 1 CARTON | CREAM | 1 | | 4 |
| 0363-4502-02 | Terbinafine 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 |
|---|
| 0363-4502 | TERBINAFINE HYDROCHLORIDE CREAM [WALGREEN COMPANY] | 3 | Current NDC, 2 package rows | 20240509_2ba1924b-9967-4adb-9061-d023ef44ab3e.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 |
|---|
| 0363-4502-02 | 00363450202 | 1 TUBE in 1 CARTON (0363-4502-02) / 30 g in 1 TUBE | 1 tube | 2023-10-25 | No | No | Historical |