Terbinafine
- Product NDC
- 76282-209
- 11-digit product format
- 762820209
- Labeler code
- 76282
- Product ID
- 76282-209_dc86cdd6-0a8a-4e5c-b3c4-8b05388af862
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Terbinafine
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- Exelan Pharmaceuticals Inc.
- Application
- ANDA077533
- Marketing category
- ANDA
- Marketing start
- 2012-04-25
- 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 |
|---|
| 76282-209-01 | Terbinafine | 100 in 1 BOTTLE | TABLET | 100 | | 6 |
| 76282-209-05 | Terbinafine | 500 in 1 BOTTLE | TABLET | 500 | | 6 |
| 76282-209-30 | Terbinafine | 30 in 1 BOTTLE | TABLET | 30 | | 6 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76282-209 | TERBINAFINE TABLET [EXELAN PHARMACEUTICALS INC.] | 6 | Current NDC, Legacy NDC, 3 package rows | 20201102_6dc279cc-9861-4fa8-8083-ca3b3c57b513.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 |
|---|
| 76282-209-01 | 76282020901 | 100 TABLET in 1 BOTTLE (76282-209-01) | 100 tablet | 2012-04-25 | 0000-00-00 | No | No | Current |
| 76282-209-05 | 76282020905 | 500 TABLET in 1 BOTTLE (76282-209-05) | 500 tablet | 2012-04-25 | 0000-00-00 | No | No | Current |
| 76282-209-30 | 76282020930 | 30 TABLET in 1 BOTTLE (76282-209-30) | 30 tablet | 2012-04-25 | 0000-00-00 | No | No | Current |