Terbinafine Hydrochloride
- Product NDC
- 51655-364
- 11-digit product format
- 516550364
- Labeler code
- 51655
- Product ID
- 51655-364_48eb9f2c-1512-e77b-e063-6394a90a5b31
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbinafine Hydrochloride
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Northwind Health Company, LLC
- Application
- ANDA077714
- Marketing category
- ANDA
- Marketing start
- 2020-05-28
- Substance
- TERBINAFINE HYDROCHLORIDE
- Active strength
- 250 mg/1
- Pharmacologic classes
- Allylamine Antifungal [EPC], Allylamine [CS]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Terbinafine Hydrochloride
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| TERBINAFINE HYDROCHLORIDE | 250 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 012C11ZU6G |
| Rxcui | 313222 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 51655-364-26 | Terbinafine Hydrochloride | 90 in 1 BOTTLE | TABLET | 90 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 51655-364 | TERBINAFINE HYDROCHLORIDE TABLET [NORTHWIND PHARMACEUTICALS, LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20241225_ab6f50a5-87ce-0819-e053-2a95a90a22b7.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 |
|---|
| 51655-364-26 | 51655036426 | 90 TABLET in 1 BOTTLE (51655-364-26) | 90 tablet | 2020-05-28 | 0000-00-00 | No | No | Current |