TERBINAFINE
- Product NDC
- 62135-572
- 11-digit product format
- 621350572
- Labeler code
- 62135
- Product ID
- 62135-572_2659c503-319a-b899-e063-6294a90aa6a6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbinafine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Chartwell RX, LLC
- Application
- ANDA078199
- Marketing category
- ANDA
- Marketing start
- 2007-07-02
- Substance
- TERBINAFINE HYDROCHLORIDE
- Active strength
- 250 mg/1
- 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
- Listing expiration
- 2026-12-31
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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 62135-572-30 | TERBINAFINE | 30 in 1 BOTTLE | TABLET | 30 | | 4 |
| 62135-572-90 | TERBINAFINE | 90 in 1 BOTTLE | TABLET | 90 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 62135-572 | TERBINAFINE TABLET [CHARTWELL RX, LLC] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241109_8ea693ec-e2f2-4661-b144-17651018e9fb.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 |
|---|
| 62135-572-30 | 62135057230 | 30 TABLET in 1 BOTTLE (62135-572-30) | 30 tablet | 2022-03-08 | 0000-00-00 | No | No | Current |
| 62135-572-90 | 62135057290 | 90 TABLET in 1 BOTTLE (62135-572-90) | 90 tablet | 2022-03-08 | 0000-00-00 | No | No | Current |